# K040883: Evotech Integrated Endoscope Disinfection System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Mar 15, 2005 after 344 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914145 (1994). 2 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914145: DSD-91(TM) Disinfector for Flexible Endoscopes, Medivators, Inc. (1994) Summary page 1.
- K991487: Cidex Opa Solution, Advanced Sterilization Products (1999) Summary page 2.

## Cited in the summary but kept off the family tree
- K032959: Cidex Opa Concentrate, Advanced Sterilization Products (2005). Our reading of the summary gave K032959, which FDA decided on Apr 4, 2005, after this device was decided (Mar 15, 2005), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1.

## Most influential descendants
- K061899: Evotech Integrated Endoscope Disinfection System (2006), 17 descendants of its own
- K082988: Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant (2009), 7 descendants of its own
- K082392: Evotech Endoscope Cleaner and Reprocessor (2008), 4 descendants of its own
- K140977: Evotech Ecr (2014), 3 descendants of its own
- K152189: Evotech Ecr (2016), 2 descendants of its own

## Recalls of this device
- Sep 27, 2016 · Class II · Z-0965-2017: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
- Feb 13, 2008 · Not classified · Z-1369-2008: Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) Interface board malfunction resulting in a
- Feb 13, 2008 · Not classified · Z-1368-2008: Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) Interface board malfunction resulting in a

## Indications for use
The EvoTech System, a washer / disinfector, is indicated for use with the high level disinfectant CIDEX® OPA Concentrate, (MEC of 0.055%, minimum temperature of 500 C for a contact time of 5 minutes) for reprocessing heat sensitive (<60 0C) semi critical endoscopes. Endoscopes must be manually cleaned prior to placement in the EvoTech System. The System includes an on-board MEC monitor, performs automated leak test, block test and post processing alcohol flush.

Source page: https://510kreport.com/device/K040883
Methodology: https://510kreport.com/methodology