# K964240: Biafine Wound Dressing Emulsion

- Pathway: 510(k) (Traditional)
- Applicant: Medix Pharmaceuticals Americas, Inc.
- Decided: Jan 22, 1997 after 90 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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.
76 later devices descend from it; 13 cite it directly.
0 of 77 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
- K024367: Sinclair Wound and Skin Emulsion (2003), 67 descendants of its own
- K041342: Impruv a.I. Cream Wound and Skin Emulsion (2005), 44 descendants of its own
- K102945: Pediacyn Atopic Dermatitis Hydrogel (2011), 17 descendants of its own
- K052643: Epiceram (2006), 16 descendants of its own
- K123071: Vashe Skin and Wound Hydrogel (2013), 11 descendants of its own

## Indications for use
BIAFINE™ is intended to be used as a wound dressing for the following indications: superficial wounds minor abrasions leg ulcers donor sites 1st and 2nd degree burns, including sunburns radiation dermatitis for dermal ulcers, including full thickness wounds and pressure sores, consult a physician

Source page: https://510kreport.com/device/K964240
Methodology: https://510kreport.com/methodology