# K092351: Poly Fit + Absorbing and High Absorbing Antimicrobial Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Polyremedy, Inc.
- Decided: Apr 8, 2010 after 247 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K121522: Polyfit Absorbing Antimicrobial Dressings (Otc) (2012), 5 descendants of its own
- 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

## Indications for use
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 under a healthcare professional's orders as adjunctive treatment in the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers (Stages II-IV), 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, for 3rd degree burns or for dry wounds.

Source page: https://510kreport.com/device/K092351
Methodology: https://510kreport.com/methodology