# K222804: Irrisept Antimicrobial Wound Lavage

- Pathway: 510(k) (Special)
- Applicant: Irrimax Corporation
- Decided: Sep 22, 2022 after 6 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K914579 (1992). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210536: Irrisept Antimicrobial Wound Lavage, Irrimax Corporation (2021) Summary page 4.

## Indications for use
Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.

Source page: https://510kreport.com/device/K222804
Methodology: https://510kreport.com/methodology