# K092387: Medivators DSD Edge Endoscope Reprocessing System

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Apr 5, 2010 after 243 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: 4 generations back to K914145 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082988: Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant, Medivators Reprocessing Systems (2009) Summary page 1.
- K914145: DSD-91(TM) Disinfector for Flexible Endoscopes, Medivators, Inc. (1994) Summary page 3.

## Recalls of this device
- Jun 13, 2024 · Class II · Z-2539-2024: IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from

## Indications for use
Medivators DSD Edge Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The DSD Edge system is indicated to provide high level disinfection, using Rapicide PA High Level Disinfectant, of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the DSD Edge system. Rapicide PA contact conditions in the DSD Edge *5 Minutes -30'C -850 ppm peracetic acid

Source page: https://510kreport.com/device/K092387
Methodology: https://510kreport.com/methodology