# K251757: Puracyn® Plus Antimicrobial Irrigation Solution

- Pathway: 510(k) (Traditional)
- Applicant: Innovacyn, Inc.
- Decided: Jan 5, 2026 after 210 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K914579 (1992). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232080: Puracyn® Plus Antimicrobial Irrigation Solution, Innovacyn, Inc. (2024) Summary page 5.

## Indications for use
Puracyn® Plus Antimicrobial Irrigation Solution is applied with irrigation for mechanical cleansing and removal of debris from wounds, including microorganisms.

Source page: https://510kreport.com/device/K251757
Methodology: https://510kreport.com/methodology