# K121522: Polyfit Absorbing Antimicrobial Dressings (Otc)

- Pathway: 510(k) (Traditional)
- Applicant: Polyremedy, Inc.
- Decided: Jun 27, 2012 after 35 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: 4 generations back to K914604 (1992). 11 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092351: Poly Fit + Absorbing and High Absorbing Antimicrobial Dressings, Polyremedy, Inc. (2010) Summary page 1.
- K070653: Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662, Tyco Healthcare (2007) Summary page 1.
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2008) Summary page 1.

## Most influential descendants
- K130857: Prontosan Wound Gel X (2013), 3 descendants of its own
- K192527: Rochal Antimicrobial Wound Gel (2020), 2 descendants of its own
- K223259: coactiv+™ Antimicrobial Wound Gel (2023), 1 descendant of its own
- K241809: coactiv+™ Antimicrobial Wound Gel (2024), 0 descendants of its own
- K221532: PHMB Wound Dressing (2023), 0 descendants of its own

## Indications for use
For Over-the-Counter Use, PolyFIT+ Absorbing Antimicrobial Dressings and PolyFIT+ High Absorbing Antimicrobial Dressings may be used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns. Under the supervision of a healthcare professional, PolyFIT+ Absorbing Antimicrobial Dressings and PolyFIT+ High Absorbing Antimicrobial Dressings may be used for the management of: PolyFIT+ Absorbing Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are for use as adjunctive treatment in the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds (including those left open to heal by secondary intention). They are not intended for wounds with exposed tendon or bone, or for 3rd degree burns.

Source page: https://510kreport.com/device/K121522
Methodology: https://510kreport.com/methodology