# K063876: Modular Disinfection System (MDS) for Endoscope Reprocessing

- Pathway: 510(k) (Traditional)
- Applicant: Medivators Reprocessing Systems
- Decided: Jun 14, 2007 after 167 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914145 (1994). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 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 2.

## Most influential descendants
- K082988: Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant (2009), 7 descendants of its own
- K152394: Rapicide PA High-Level Disinfectant Test Strips (2016), 2 descendants of its own
- K192228: CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant (2020), 1 descendant of its own
- K251035: DISINTEK™ PA Test Strips (2025), 0 descendants of its own
- K251048: Rapicide PA High-Level Disinfection Test Strip  Model Ref # = ML02-0118 (2025), 0 descendants of its own

## Indications for use
Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing tests, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The MDS is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes, It is indicated for use with FDA cleared, liquid high level disinfectants, The MDS does not replace manual cleaning of endosoopes, they must be preclesned and cleaned according to the endoscope manufacturer's instructions and professional guidelines prior to reprocessing them in the MADS.

Source page: https://510kreport.com/device/K063876
Methodology: https://510kreport.com/methodology