# K190224: Medline Burn and Wound Dressing (OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Mar 8, 2019 after 31 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: 8 generations back to K914579 (1992). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173911: Medline Burn and Wound Dressing, Medline Industries, Inc. (2018) Summary page 4.
- K101882: Prontosan Antimicrobial Wound Gel, B.Braun Medical, Inc. (2010) Summary page 4.

## Indications for use
Over-the-Counter Use: Medline Burn and Wound Dressing is intended to moisten the wound and for the management of minor cuts, minor abrasions, minor lacerations and minor burns.

Source page: https://510kreport.com/device/K190224
Methodology: https://510kreport.com/methodology