# K162120: Scope-Assist Flushing Sink

- Pathway: 510(k) (Traditional)
- Applicant: Custom Ultrasonics, Inc.
- Decided: Apr 28, 2017 after 270 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 K000216 (2000). 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)
- K000216: PSK Endoscope Cleaning System, Psk Connectors Pty, Ltd. (2000) Summary page 4.

## Indications for use
The Scope-Assist Flushing Sink is indicated for flushing the channels of flexible endoscopes according to the endoscope manufacturer's instructions.

Source page: https://510kreport.com/device/K162120
Methodology: https://510kreport.com/methodology