# K122172: System 83 Plus

- Pathway: 510(k) (Special)
- Applicant: Custom Ultrasonics
- Decided: Jan 25, 2013 after 186 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K173590: System 83 Plus Washer/Disinfector (2020), 1 descendant of its own
- K241168: System 83 Revolve Endoscope Washer/Disinfector (2024), 0 descendants of its own

## Recalls of this device
- Mar 12, 2013 · Class II · Z-0426-2014: Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.

## Indications for use
System 83 Plus Endoscope Washerlbisinfector is designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinai and/or pulmonary tracts. Flexible scopes that are precleaned and then exposed to the.washngdisnfeclOfl cycle of the System 83 Plus may be high level disintected when the disinfection cycle corresponds to the labeled contact conditions for the germicide as In the predicated device. Note: System 83 Plus device Includes two models. The System 83 Plus 2 Isa device with one processing chamber which can process I to 2 flexible endo scopes at a time. The System 83 Plus 9 Is two 'System 83 Plus 2' units put together. It has two processing chambers which can process 1 to 2 flexible endoscopes in each Independently operated processing chamber.

Source page: https://510kreport.com/device/K122172
Methodology: https://510kreport.com/methodology