# K210987: IRRIGO Wound Wash Jet System

- Pathway: 510(k) (Traditional)
- Applicant: Inopro, Inc.
- Decided: May 31, 2022 after 425 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). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090848: Premier Sterile Saline Wound Wash, Models 210 ML, WWM, Premier Brands of America, Inc. (2009) Summary page 4.
- K082330: Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation, Primary Care Solutions, Inc. (2008) Summary page 4.

## Indications for use
IRRIGO Wound Wash Jet System is intended for use by or under the direction of a professional healthcare provider in moistening and lubricating absorbent wound dressings, cleansing, and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts, abrasions, and minor burns.

Source page: https://510kreport.com/device/K210987
Methodology: https://510kreport.com/methodology