# K082392: Evotech Endoscope Cleaner and Reprocessor

- Pathway: 510(k) (Special)
- Applicant: Advanced Sterilization Products
- Decided: Nov 13, 2008 after 86 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: 3 generations back to K914145 (1994). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061899: Evotech Integrated Endoscope Disinfection System, Advanced Sterilization Products (2006) Summary page 1.

## Most influential descendants
- K140977: Evotech Ecr (2014), 3 descendants of its own
- K152189: Evotech Ecr (2016), 2 descendants of its own
- K230930: enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (2023), 1 descendant of its own
- K243433: enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (2024), 0 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.
- Mar 28, 2013 · Class II · Z-1150-2013: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malf
- Mar 22, 2013 · Class II · Z-1123-2013: Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing.

## Indications for use
The EVOTECHTM Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX® OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high level disinfection of heat sensitive (>60 0C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH System when selecting those cycles that contain a wash stage. (Manual cleaning of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)

Source page: https://510kreport.com/device/K082392
Methodology: https://510kreport.com/methodology