# K061899: Evotech Integrated Endoscope Disinfection System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Oct 26, 2006 after 115 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K914145 (1994). 3 ancestors in all.
17 later devices descend from it; 4 cite 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)
- K040883: Evotech Integrated Endoscope Disinfection System, Advanced Sterilization Products (2005) Summary page 1.

## Most influential descendants
- 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
- K152394: Rapicide PA High-Level Disinfectant Test Strips (2016), 2 descendants of its own

## Recalls of this device
- 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 TM System, 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 (>600 C) 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 is required when selecting the Disinfect Only or Disinfect/Alcohol Flush Cycles.)

Source page: https://510kreport.com/device/K061899
Methodology: https://510kreport.com/methodology