# K112191: Healex Biosponge Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Bionova Medical, Inc.
- Decided: Jun 5, 2012 after 312 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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: 2 generations back to K984264 (1999). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071552: Puracol Plus AG Collagen Microscaffold Wound Dressing, Medline Industries, Inc. (2008) Summary page 1.
- K080010: Nocc Hydrophilic Wound Dressing, Kytogenics, Inc. (2008) Summary page 1.
- K092552: Clo-Surplus P.a.D., Scion Cardio-Vascular, Inc. (2009) Summary page 1.

## Most influential descendants
- K123961: Sentrex Biosponge MPD (2013), 4 descendants of its own
- K210949: Foundation Dermal Regeneration Scaffold (DRS) Solo (2022), 3 descendants of its own
- K231937: Foundation Dermal Regeneration Scaffold (DRS) Solo (2023), 2 descendants of its own
- K240298: Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (2024), 1 descendant of its own
- K243181: Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (2024), 0 descendants of its own

## Indications for use
The Sentrex SBiSponge Wound Dressing is indicated in the dressing and management of: * Full thickness and partial thickness wounds * Pressure ulcers * Venous ulcers * Ulcers caused by mixed vascular etiologies * Diabetic ulcers * First and second degree burns * Donor sites and other bleeding surface wounds * Abrasions * Trauma wounds healing by secondary intention * Dehisced wounds * Surgical wounds * Dehisced surgical wounds

Source page: https://510kreport.com/device/K112191
Methodology: https://510kreport.com/methodology