# K253267: CORIS System

- Pathway: 510(k) (Traditional)
- Applicant: Nanosonics Limited
- Decided: Mar 5, 2026 after 157 days
- Product code: SEW (Automated Endoscope Channel Cleaner)
- Device class: 2
- Regulation: 21 CFR 880.6994
- 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 DEN240018 (2025). 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)
- DEN240018: CORIS System, Nanosonics Limited (2025) Summary page 5.

## Indications for use
The Nanosonics CORIS System is indicated for cleaning of the channels of compatible endoscopes. The CORIS System is suitable for use in healthcare facilities by trained healthcare personnel.

Source page: https://510kreport.com/device/K253267
Methodology: https://510kreport.com/methodology