# K092348: Poly Fit  High Hydrating 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
PolyFIT+ High Hydrating Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ High Hydrating Antimicrobial Dressings are indicated for use under a healthcare professional's orders as adjunctive treatment to maintain a moist wound environment in the management of dry wounds or wounds with minimal to no exudate, in the care of partial or 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 and for 3rd degree burns.

Source page: https://510kreport.com/device/K092348
Methodology: https://510kreport.com/methodology