# K080779: Irrisept Wound Cleansing System

- Pathway: 510(k) (Traditional)
- Applicant: Irrimax Corporation
- Decided: Feb 4, 2009 after 322 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945802 (1995). 10 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022670: Carraklenz and Ultraklenz, Carrington Laboratories, Inc. (2002) Summary page 1.
- K970660: Dermagran Wound Management System, Derma Sciences, Inc. (1997) Summary page 1.
- K954743: Dermagran Wound Dressing Cleaner W/Zinc, Derma Sciences, Inc. (1995) Summary page 1.
- K945802: Dermagran Wound Cleanser with Zinc, Derma Sciences, Inc. (1995) Summary page 1.
- K003229: Biopatch Antimicrobial Dressing, Integra Lifesciences Corp. (2001) Summary page 1.

## Most influential descendants
- K202222: Irrisept Wound Debridement and Cleansing System (2020), 7 descendants of its own
- K210536: Irrisept Antimicrobial Wound Lavage (2021), 6 descendants of its own
- K202071: SURGIPHOR Wound Irrigation System (2020), 4 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

## Recalls of this device
- Aug 16, 2019 · Class II · Z-0191-2020: Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
- Sep 5, 2017 · Class II · Z-0490-2019: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

## Indications for use
The IRRISEPTTM 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/K080779
Methodology: https://510kreport.com/methodology