# Bionova Medical, Inc.

- Location (FDA's records): Germantown, TN
- FDA decisions: 6 (2012–2024): 6 510(k) clearances
- Product codes: KGN (4), FRO (2)
- 510(k) review time since 2016: median 169 days, against 255 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 16 (6 its own); citations of its devices by later devices: 6 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medline Industries, Inc.: 2 (https://510kreport.com/company/medline-industries)
- Kytogenics, Inc.: 1 (https://510kreport.com/company/kytogenics)
- Scion Cardio-Vascular, Inc.: 1 (https://510kreport.com/company/scion-cardio-vascular)
- Polynovo Biomaterials Pty, Ltd.: 1 (https://510kreport.com/company/polynovo-biomaterials)
- Kensey Nash Corp.: 1 (https://510kreport.com/company/kensey-nash)
- Molnlycke Health Care, Inc.: 1 (https://510kreport.com/company/molnlycke-health-care)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Coloplast Corp.: 1 (https://510kreport.com/company/coloplast)

## Its most-cited devices
- K231937: Foundation Dermal Regeneration Scaffold (DRS) Solo (2023), cited by 2
- K112191: Healex Biosponge Wound Dressing (2012), cited by 1
- K240298: Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (2024), cited by 1
- K210949: Foundation Dermal Regeneration Scaffold (DRS) Solo (2022), cited by 1
- K123961: Sentrex Biosponge MPD (2013), cited by 1

## Recent decisions
- K243181: Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (Oct 31, 2024)
- K240298: Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (Aug 21, 2024)
- K231937: Foundation Dermal Regeneration Scaffold (DRS) Solo (Nov 13, 2023)
- K210949: Foundation Dermal Regeneration Scaffold (DRS) Solo (Aug 11, 2022)
- K123961: Sentrex Biosponge MPD (Apr 5, 2013)
- K112191: Healex Biosponge Wound Dressing (Jun 5, 2012)

Source page: https://510kreport.com/company/bionova-medical