# K152189: Evotech Ecr

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products (Asp)
- Decided: Jul 20, 2016 after 350 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914145 (1994). 6 ancestors in all.
2 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)
- K140977: Evotech Ecr, Advanced Sterilization Products (2014) Summary page 4.

## Most influential descendants
- 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.

## Indications for use
The EVOTECH® ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX® OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60°C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH® ECR Endoscope Cleaner and Reprocessor 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/K152189
Methodology: https://510kreport.com/methodology