510(k) · Cleared
ClearedSentrex Biosponge MPD
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 Apr 5, 2013 as substantially equivalent to K112191 (Bionova Medical, Inc., 2012) and 5 other predicates after a 100-day review. Its family tree reaches back 5 generations to 1992. 4 later devices descend from it.
- Decided
- Apr 5, 2013
- Review
- 100 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K914579 (1992). 41 ancestors in all, the oldest K871166 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 4 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 3 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 2 generations backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- 1 generation backK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- This deviceK123961 Sentrex Biosponge MPDBionova Medical, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK210949 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK231937 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK240298 Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK243181 Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022 · cites it directly3descendants
- K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023 · 2 generations on2descendants
- K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024 · 3 generations on1descendant
- K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −4 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −3 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −2 | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| −1 | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | Coloplast Corp. | 2004 | — |
| 0 (this device) | K123961 | Sentrex Biosponge MPD | Bionova Medical, Inc. | 2013 | — |
| +1 | K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2022 | — |
| +2 | K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2023 | — |
| +3 | K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | 2024 | — |
| +3 | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K112191 | Healex Biosponge Wound DressingSummary page 1…me: Sentrex BioSponge MPD Common Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Codes: FRO Predicate Device(s): *K1 12191, Sentrex BioSponge Wound Dressing * K071552, Puracol Plus AG Collagen Microscaffold BioSponge * K984371, Mepitel Non-… | 2012 |
| * | K071552 | Puracol Plus AG Collagen Microscaffold Wound DressingSummary page 1…Dressing, Wound, Drug Regulatory Class: Unclassified Product Codes: FRO Predicate Device(s): *K1 12191, Sentrex BioSponge Wound Dressing * K071552, Puracol Plus AG Collagen Microscaffold BioSponge * K984371, Mepitel Non-Adherent Silicone Dressing * K0831 13, ACTIC… | 2008 |
| * | K984371 | Mepitel Non Adherent Silicone DressingSummary page 1…oduct Codes: FRO Predicate Device(s): *K1 12191, Sentrex BioSponge Wound Dressing * K071552, Puracol Plus AG Collagen Microscaffold BioSponge * K984371, Mepitel Non-Adherent Silicone Dressing * K0831 13, ACTICOAt Flex 7 Dressing * K033869, Contreet Foam Cavity Dressing… | 1999 |
| * | K083113 | Acticoat Flex 7 DressingSummary page 1…12191, Sentrex BioSponge Wound Dressing * K071552, Puracol Plus AG Collagen Microscaffold BioSponge * K984371, Mepitel Non-Adherent Silicone Dressing * K0831 13, ACTICOAt Flex 7 Dressing * K033869, Contreet Foam Cavity Dressing with Silver * K081635, INTEGRA Meshed Bilayer Woun… | 2009 |
| * | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Summary page 1…* K071552, Puracol Plus AG Collagen Microscaffold BioSponge * K984371, Mepitel Non-Adherent Silicone Dressing * K0831 13, ACTICOAt Flex 7 Dressing * K033869, Contreet Foam Cavity Dressing with Silver * K081635, INTEGRA Meshed Bilayer Wound Matrix Device Description: The Sentrex… | 2004 |
| * | K081635 | Integra Meshed Bilayer Wound MatrixSummary page 1…nge * K984371, Mepitel Non-Adherent Silicone Dressing * K0831 13, ACTICOAt Flex 7 Dressing * K033869, Contreet Foam Cavity Dressing with Silver * K081635, INTEGRA Meshed Bilayer Wound Matrix Device Description: The Sentrex BioSponge MPD is a sterile, porous, soft chitosan sponge d… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo | 2022 | 3 |
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 21 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 41 ancestors have a recall of any class.
- Of its descendants, K210949 (Bionova Medical, Inc., 2022) has gone furthest, with 3 descendants of its own.
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. 2013, 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 BioSponge MPD 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
* Grafts
The Sentrex BioSponge MPD may be cut to size.
The Sentrex BioSponge MPD is indicated for wounds with moderate to high amounts of exudate, and may be used in conjunction with negative pressure wound therapy (NPWT).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123961: Sentrex Biosponge MPD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123961
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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