510(k) · Cleared
ClearedHealex Biosponge Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionova Medical, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jun 5, 2012 as substantially equivalent to K071552 (Medline Industries, Inc., 2008) and 2 other predicates after a 312-day review. Its family tree reaches back 2 generations to 1999. 5 later devices descend from it.
- Decided
- Jun 5, 2012
- Review
- 312 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K984264 (1999). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK984264 Modification of Bionect Clear HydrogelFidia Pharmaceutical Corp. · 1999
- 1 generation backK080010 Nocc Hydrophilic Wound DressingKytogenics, Inc. · 2008
- This deviceK112191 Healex Biosponge Wound DressingBionova Medical, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK123961 Sentrex Biosponge MPDBionova Medical, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK210949 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK231937 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK240298 Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK243181 Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K123961Sentrex Biosponge MPDBionova Medical, Inc. · 2013 · cites it directly4descendants
- K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022 · 2 generations on3descendants
- K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023 · 3 generations on2descendants
- K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024 · 4 generations on1descendant
- K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K984264 | Modification of Bionect Clear Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| −1 | K080010 | Nocc Hydrophilic Wound Dressing | Kytogenics, Inc. | 2008 | — |
| 0 (this device) | K112191 | Healex Biosponge Wound Dressing | Bionova Medical, Inc. | 2012 | — |
| +1 | K123961 | Sentrex Biosponge MPD | Bionova Medical, Inc. | 2013 | — |
| +2 | K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2022 | — |
| +3 | K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2023 | — |
| +4 | K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | 2024 | — |
| +4 | K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | Bionova Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071552 | Puracol Plus AG Collagen Microscaffold Wound DressingSummary page 1…Name: Sentrex Bioponge Wound Dressing Common Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Codes: FRO Predicate Device(s): * K071552, Puracol Pius AG Collagen Microscaffold RioSponge * K080010, NOCO Hydrophilic RioSponge * K092552, Scion Cardiovascul… | 2008 |
| * | K080010 | Nocc Hydrophilic Wound DressingSummary page 1…Dressing, Wound, Drug Regulatory Class: Unclassified Product Codes: FRO Predicate Device(s): * K071552, Puracol Pius AG Collagen Microscaffold RioSponge * K080010, NOCO Hydrophilic RioSponge * K092552, Scion Cardiovascular Clo-SurPLus P.A.D. Device Description: The Sentrex RioSponge… | 2008 |
| * | K092552 | Clo-Surplus P.a.D.Summary page 1…assified Product Codes: FRO Predicate Device(s): * K071552, Puracol Pius AG Collagen Microscaffold RioSponge * K080010, NOCO Hydrophilic RioSponge * K092552, Scion Cardiovascular Clo-SurPLus P.A.D. Device Description: The Sentrex RioSponge Wound Dressing is a sterile, porous, soft ch… | 2009 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123961 | Sentrex Biosponge MPD | 2013 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K123961 (Bionova Medical, Inc., 2013) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K071552.
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112191 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112191: Healex Biosponge Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112191
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026