FDA 510(k)s Cleared for Sterilants and High Level Disinfectants

The following 510(k)s are a representative list of those cleared for processing reusable medical and dental devices

21 CFR 880.6885 Liquid chemical sterilants/high level disinfectants.

(a) Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

(b) Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.

Product Codes under 21 CFR 880.6885

LFE 2 Solution, Cold Sterilizing 880.6885
MED 2 Sterilant, Medical Devices 880.6885

A Representative 510(k)s Cleared under Product Code “MED”

System 1e Liquid Chemical Sterilant Proc Steris Corporation K131078 07/05/2013
Rapicide Opa-28 Minntech Corp. K120306 09/27/2012
System 1e Liquid Chemical Sterilant Proc Steris Corporation K113520 02/21/2012
Aldahol V High Level Disinfectant Microchem Laboratories, Inc. K113015 01/30/2012
System 1e Liquid Chemical Sterilant Proc Steris Corporation K102462 09/21/2010
System Ie Liquid Chemical Cterilant Proc Steris Corporation K101409 08/02/2010
Modification To Resert Xl Hld High Level Steris Corporation K091022 04/12/2010
System 1.5 Sterile Processing System Steris Corporation K090036 04/05/2010
Extended Use Aldahol High Level Disinfec Healthpoint, Ltd. K091890 03/24/2010
Acecide-C High Level Disinfectant And St Best Sanitizers, Inc. K091210 02/05/2010

Additional 510(k)s

Manufacturer Active Ingredient(s) Sterilant Contact Conditions High Level
Disinfectant Contact Conditions
K051305  TD-5 High-level Disinfectant
CS Medical, L.L.C. 2.65% glutaraldehyde No indication for device sterilization.Passes the AOAC Sporicidal Activity Test in 10 hrs at 22 °C. 5 min at 37.8ºC
Single use to be used exclusively with the TD-100 Transesophageal Probe Disinfector.
Contact conditions established by simulated use testing with endoscopes.
K041984 Acecide™ High Level Disinfectant and Sterilant
Minntech Corp 8.3% hydrogen peroxide
7.0% peracetic acid
Indication for device sterilization.5 hrs at 25°C
5 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
5 min at 25°C
5 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes
K041360 Aldahol III High Level Disinfectant
Healthpoint LTD 3.4% glutaraldehyde
26% isopropanol
Indication for device sterilization.10 hrs at 20° C
Contact conditions based on AOAC Sporicidal Activity Test only.
10 min at 20ºC
14 days Maximum Reuse 
Contact conditions established by simulated use testing with endoscopes.
K012889 Banicide Advanced for Sterilization and High Level Disinfection
Pascal Company, Inc. 3.5% glutaraldehyde Indication for device sterilization.10 hrs at 25°C
30 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
45 min at 25°C
30 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
K032959 Cidex® OPA Concentrate
Advanced Sterilization Products 5.75% ortho-phthaldehyde (OPA) No indication for device sterilization.In-Use solution (0.05% OPA) passes the AOAC Sporicidal Activity Test in 32 hrs at 50°C. 5 min at 50ºC
Single use – diluted by system
For use in the EvoTech Integrated Endoscope Disinfection System only.
Contact conditions established by simulated use testing with endoscopes.
K030004 Cidex OPA Solution
Advanced Sterilization Products 0.55% ortho-phthaldehyde No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 32 hrs at 20°C and 25°C. Manual Processing
12 min at 20°C
14 days Maximum ReuseAutomated Endoscope Reprocessor (AER)
5 min at 25°C
14 days Maximum Reuse
(For processing in an AER only with FDA-cleared capability to maintain solution temperature at 25°C.) Contact conditions established by simulated use testing with endoscopes.
K013280 Sterilox Liquid High Level Disinfectant System
Sterilox, Technologies, Inc. Hypochlorite and
Hypochlorous acid 650-675 ppm Active free chlorine
No indication for device sterilization. Passes the Modified AOAC Sporicidal Activity Test in 24 hrs at 25°C. 10 min at 25°C
Single use – generated on site
Contact conditions established by simulated use testing with endoscopes.
K003087 Sporicidin Sterilizing and Disinfecting Solution
Sporicidin International 1.12% glutaraldehyde
1.93% phenol/phenate
Indication for device sterilization.
12 hrs at 25°C
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
20 min at 25°C
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
K993042 Rapicide High Level Disinfectant and Sterilant
MediVators, Inc. 2.5% glutaraldehyde Indication for device sterilization.
7 hrs 40 min at 35°C
28 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes and additional supporting information.
Automated Endoscope Reprocessor
5.0 min at 35°C
28 days Maximum Reuse
(For processing in an AER only with FDA-cleared capability to maintain the solution temperature at 35°C.)
Contact conditions established by simulated use testing with endoscopes.
K991487 °Cidex®OPA Solution High Level Disinfectant
Advanced Sterilization Products 0.55% ortho-phthaldehyde No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 32 hrs at 20°C. 12 min at 20°C
14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K974188 °Cetylcide-G Concentrate and Diluent Concentrate
Cetylite Industries, Inc. 3.2% glutaraldehyde Indication for device sterilization.
10 hrs at 20°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
40 min at 20°C
28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K974062 MedSci 3% Glutaraldehyde
MedSci, Inc. 3% glutaraldehyde Indication for device sterilization. 10 hrs at 25°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
25 min at 25°C
28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K972708 EndoSpor Plus Sterilizing and Disinfecting Solution
Note: Due to the lack of test strips for monitoring the concentrations of the active ingredients, the reuse period is limited to 14 days.
Cottrell Limited 7.35% hydrogen peroxide
0.23% peracetic acid
Indication for device sterilization.
180 min at 20°C
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
15 min at 20°C
14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K970230 SporoxTM Sterilizing & Disinfection Solution
Reckitt & Colman Inc. 7.5% hydrogen peroxide Indication for device sterilization.
6 hrs at 20°C
21 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
30 min at 20°C
21 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K960513 PeractTM 20 Liquid Sterilant/Disinfectant
Minntech Corporation 1.0% hydrogen peroxide
0.08% peracetic acid
Indication for device sterilization.
8 hrs at 20°C
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
25 min at 20°C
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
K932922 Procide 14 N.S.
Cottrell Limited 2.4% glutaraldehyde Indication for device sterilization.
10 hrs at 20°C
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
45 min at 20°C
14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K932922 OmnicideTM Long Life Activated Dialdehyde Solution
Cottrell Limited 2.4% glutaraldehyde Indication for device sterilization.
10 hrs at 20°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
45 min at 20°C
28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K932922 OmnicideTM Plus
Cottrell Limited 3.4% glutaraldehyde Indication for device sterilization.
10 hrs at 20°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
45 min at 20°C
28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K931592 Metricide Plus 30 Long-Life Activated Dialdehyde Solution
Metrex Research, Inc. 3.4% glutaraldehyde Indication for device sterilization.
10 hrs at 25°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide Plus as identical to Cidex Plus.
90 min at 25°C
28 days Maximum Reuse
FDA accepted Metricide Plus as identical to Cidex Plus.
K931052 Metricide 28 Long-Life Activated Dialdehyde Solution
Metrex Research, Inc. 2.5% glutaraldehyde Indication for device sterilization.
10 hrs at 25°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide 28 as identical to Cidex Formula 7.
90 min at 25°C
28 days Maximum Reuse
FDA accepted Metricide 28 as identical to Cidex Formula 7.
K930284 Metricide Activated Dialdehyde Solution
Metrex Research, Inc. 2.6% glutaraldehyde Indication for device sterilization.
10 hrs at 25°C
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide as identical to Cidex.
45 min at 25°C
14 days Maximum Reuse
FDA accepted Metricide as identical to Cidex.
K924434 Cidex™ Activated Dialdehyde Solution
Johnson & Johnson Medical Products 2.4% glutaraldehyde Indication for device sterilization.
10 hrs at 25°C
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
45 min at 25°C
14 days Maximum Reuse Contact conditions based on literature references.
K924334 Cidex Formula 7™ Long-Life Activated Dialdehyde Solution
Johnson & Johnson Medical Products 2.5% glutaraldehyde Indication for device sterilization.
10 hrs at 20-25°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
90 min at 25°C
28 days Maximum Reuse
Contact conditions based on literature references.
K923744 Cidex PlusTM 28 Day Solution
Johnson & Johnson Medical Products 3.4% glutaraldehyde Indication for device sterilization.
10 hrs at 20-25°C
28 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
20 min at 25°C
28 days Maximum Reuse Contact conditions based on literature references.
K914749 Wavicide – 01
Wave Energy Systems 2.5% glutaraldehyde Indication for device sterilization.
10 hrs at 22°C
30 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test only.
45 min at 22°C
30 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K875280 STERIS 20TM Sterilant
Note: Cleared for use with the STERIS System 1TM Processor only.
STERISCorporation 0.2% peracetic acid Indication for device sterilization.
12 min at 50-56°C
Single use only.
Contact conditions established by simulated use testing with endoscopes and passing a modified AOAC Sporicidal Activity Test.
No indication for high level disinfection.
K080420 Resert XL HLD High Level Disnfectant
Steris Corporation 2.0% Hydrogen peroxide No indication for device sterilization.
In-Use solution passes the AOAC Sporicidal Activity Test in 6 hrs at 20 °C
8 min at 20ºC
21 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
K070627 Opaciden Solution
Ciden Technologies, LLC 0.60% ortho-phthalaldehyde (OPA)  No indication for device sterilization.
In-Use solution passes the AOAC Sporicidal Activity Test in 32 hrs at 21 ° C and 32 hrs at 25-27°C.
For Manual Processing:
12 min at 20ºC
14 days Maximum Reuse
For processing in a legally marketed Automated Endoscope Reprocessor capable of maintaining solution temperature at 25ºC:
5 min at 25ºC
14 days Maximum Reuse
Contact conditions established by simulated use testing with endoscopes.
K063159 Sterilox High Level Disinfectant System
Sterilox, Technologies, Inc. Hypochlorous acid/hypochlorite
400-450 ppm Active free chlorine
No indication for device sterilization.
Passes the Modified AOAC Sporicidal Activity Test in 32 hrs at 30 ° C.
10 min at 30ºC
Single use – generated on site
Contact conditions established by simulated use testing with endoscopes.
K060618 Cidex Activated Dialdehyde Solution
Advanced Sterilization Products 2.4% glutaraldehyde 10 hrs at 25 °C
14 days Maximum Reuse
Contact conditions based on AOAC Sporicidal Activity Test and by simulated use testing with endoscopes.

21 CFR PART 876 — GASTROENTEROLOGY-UROLOGY DEVICES

Subpart B–Diagnostic Devices

21 CFR 876.1500 Endoscope and accessories.

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user’s eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification: Class II (performance standards).

Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in 876.9.

21 PART 880 — GENERAL HOSPITAL AND PERSONAL — USE DEVICES

Subpart G–General Hospital and Personal Use Miscellaneous Devices

Source: FDA

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Last Updated: 2015-09-15

FDA-Cleared Sterilants and High Level Disinfectants
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