# K983017: Modification to System 83 Plus

- Pathway: 510(k) (Special)
- Applicant: Custom Ultrasonics
- Decided: Sep 22, 1998 after 25 days
- Product code: NVE (Washer, Cleaner, Automated, 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
No predicates in its family tree.
9 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K043314: Manzi Cleaner System (2005), 8 descendants of its own
- K073112: DA Vinci Sonicpro Cleaning System, Model 400253 (2008), 5 descendants of its own
- K190081: RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (2019), 4 descendants of its own
- K200577: RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (2020), 3 descendants of its own
- K203199: RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector (2020), 2 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.
- Feb 11, 2008 · Not classified · Z-1182-2008: Inadvertent selection of the "wash" cycle

## Indications for use
I certify that, in my capacity as President of Custom Ultrasonics, Inc., that the System 83 Plus Endoscope Washer/Disinfector is designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible scopes that are precleaned 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 labeled contact conditions for the germicide as in the predicated device

Source page: https://510kreport.com/device/K983017
Methodology: https://510kreport.com/methodology