# K173590: System 83 Plus Washer/Disinfector

- Pathway: 510(k) (Traditional)
- Applicant: Custom Ultrasonics, Inc.
- Decided: Mar 30, 2020 after 860 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 K122172 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122172: System 83 Plus, Custom Ultrasonics (2013) Summary page 4.

## Most influential descendants
- K241168: System 83 Revolve Endoscope Washer/Disinfector (2024), 0 descendants of its own

## Indications for use
System 83 Plus™ Washer/Disinfector is designed for the simultaneous high level disinfection of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible endoscopes that are pre-cleaned and manually cleaned, and then exposed to the washing /disinfection cycle of the System 83 Plus™, may be high level disinfected when the disinfection cycle corresponds to the System 83 Plus™ validated contact conditions of the high level disinfectant. Note: The System 83 Plus™ device includes two models. * The System 83 Plus™ 2 has one processing chamber that can process 1 to 2 flexible endoscopes at a time. * The System 83 Plus™ 9 has two processing chambers that can process 1 to 2 flexible endoscopes at a time in each independently operated processing chamber for a total of up to 4 endoscopes simultaneously.

Source page: https://510kreport.com/device/K173590
Methodology: https://510kreport.com/methodology