# K181865: Acu-sInQ Complete Endoscope Cleaning Aid System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Dec 14, 2018 after 155 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: 1 generation back to K914524 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914524: Fluid Pump, CP #3, United States Endoscopy Group, Inc. (1994) Summary page 5.

## Recalls of this device
- Oct 7, 2020 · Class III · Z-0458-2021: Potential for cleaning solution intrusion into endoscope

## Indications for use
The Acu-sInQ Complete Endoscope Cleaning Aid System is intended to assist manual flexible endoscope cleaning according to the instructions provided by the endoscope manufacturer, by facilitating performance of a leak test, accurate detergent dosing with water temperature monitoring, channel flushing, rinsing, and process documentation.

Source page: https://510kreport.com/device/K181865
Methodology: https://510kreport.com/methodology