# K210536: Irrisept Antimicrobial Wound Lavage

- Pathway: 510(k) (Traditional)
- Applicant: Irrimax Corporation
- Decided: May 28, 2021 after 93 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: 7 generations back to K914579 (1992). 35 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202222: Irrisept Wound Debridement and Cleansing System, Irrimax Corporation (2020) Summary page 4.
- K160192: Atteris Antimicrobial Skin & Wound Cleanser, Rochal Industries, LLC (2016) Summary page 4.

## Most influential descendants
- 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
- K240552: Irrisept Antimicrobial Wound Lavage (2024), 0 descendants of its own

## 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/K210536
Methodology: https://510kreport.com/methodology