# K202222: Irrisept Wound Debridement and Cleansing System

- Pathway: 510(k) (Traditional)
- Applicant: Irrimax Corporation
- Decided: Dec 14, 2020 after 130 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: 4 generations back to K945802 (1995). 11 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080779: Irrisept Wound Cleansing System, Irrimax Corporation (2009) Summary page 4.

## Most influential descendants
- K210536: Irrisept Antimicrobial Wound Lavage (2021), 6 descendants of its own
- K213616: BD Surgiphor Antimicrobial Irrigation System (2022), 3 descendants of its own
- K221504: BD Surgiphor™ Antimicrobial Irrigation System (2022), 2 descendants of its own
- K253996: BD Surgiphor™ Antimicrobial Irrigation System (910110) (2026), 0 descendants of its own
- K253445: BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (2026), 0 descendants of its own

## Indications for use
The Irrisept Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.

Source page: https://510kreport.com/device/K202222
Methodology: https://510kreport.com/methodology