510(k) · Cleared
ClearedBridge Extracellular Collegen Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harbor Medtech, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Feb 26, 2013 as substantially equivalent to K071425 (Pegasus Biologics, Inc., 2007) and 1 other predicate after a 194-day review. Its family tree reaches back 5 generations to 1988. 1 later device descends from it.
- Decided
- Feb 26, 2013
- Review
- 194 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K881854 (1988). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 4 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 3 generations backK040283 BiopadEuroresearch Srl · 2005
- 2 generations backK061494 Dermadapt Wound DressingPegasus Biologics, Inc. · 2006
- 1 generation backK071425 Unite BiomatrixPegasus Biologics, Inc. · 2007
- This deviceK122502 Bridge Extracellular Collegen MatrixHarbor Medtech, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK140367 Architect PX Extracellular Collagen MatrixHarbor Medtech, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140367Architect PX Extracellular Collagen MatrixHarbor Medtech, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −4 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −3 | K040283 | Biopad | Euroresearch Srl | 2005 | — |
| −2 | K061494 | Dermadapt Wound Dressing | Pegasus Biologics, Inc. | 2006 | — |
| −1 | K071425 | Unite Biomatrix | Pegasus Biologics, Inc. | 2007 | — |
| 0 (this device) | K122502 | Bridge Extracellular Collegen Matrix | Harbor Medtech, Inc. | 2013 | — |
| +1 | K140367 | Architect PX Extracellular Collagen Matrix | Harbor Medtech, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K071425 | Unite BiomatrixSummary page 2…arbor MedTech BriDGE ECM Wound Dressing is substantially equivalent to the following predicate devices: Pegasus Biologics Inc., UniteTm Biomatrix Collagen Wound Dressing K071425, and Cook Biotech, Inc., Oasis Wound Dressing K06171 1. The BriDGE Extracellular Collagen Matrix Wound Dressing has the same int… | 2007 |
| * | K061711 | Oasis Wound MatrixSummary page 2…ly equivalent to the following predicate devices: Pegasus Biologics Inc., UniteTm Biomatrix Collagen Wound Dressing K071425, and Cook Biotech, Inc., Oasis Wound Dressing K06171 1. The BriDGE Extracellular Collagen Matrix Wound Dressing has the same intended use as the predicate devices and incorporates the… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140367 | Architect PX Extracellular Collagen Matrix | 2014 | 0 |
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 25 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K140367 (Harbor Medtech, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K071425.
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 Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing is indicated for the local management of moderately to heavy exuding wounds, including:
* Partial and full thickness wounds,
* Draining wounds,
* Pressure sores/ulcers,
* Venous ulcers,
* Chronic vascular ulcers,
* Diabetic ulcers,
* Trauma wounds (e.g., abrasions, lacerations, partial thickness bums, skin tears),
* Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dlehisced surgical incisions)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122502 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122502: Bridge Extracellular Collegen Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122502
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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