# K935096: Biolex Impregnated Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Feb 17, 1994 after 118 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.
18 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K053538: Modification to Phytacare Alginate Hydrogel Wound Filler (2006), 15 descendants of its own
- K081584: Derma Sciences Otc Medihoney Dressings with Active Manuka Honey (2008), 14 descendants of its own
- K092689: Manukapli Wound Dressing (2010), 10 descendants of its own
- K121227: Manuka Fill (2012), 4 descendants of its own
- K131796: Manuka Fill Wound Dressing (2014), 3 descendants of its own

Source page: https://510kreport.com/device/K935096
Methodology: https://510kreport.com/methodology