# K173911: Medline Burn and Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jul 19, 2018 after 209 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: 7 generations back to K914579 (1992). 47 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101882: Prontosan Antimicrobial Wound Gel, B.Braun Medical, Inc. (2010) Summary page 4.
- K131796: Manuka Fill Wound Dressing, Links Medical Products, Inc. (2014) Summary page 4.

## Most influential descendants
- K254191: IWD-Gel™ (2026), 0 descendants of its own
- K190224: Medline Burn and Wound Dressing (OTC) (2019), 0 descendants of its own

## Indications for use
Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue.

Source page: https://510kreport.com/device/K173911
Methodology: https://510kreport.com/methodology