510(k) · Cleared
Recalled · Class II · 2019Integra Flowable Wound Matrix, Model FWD301
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Oct 10, 2007 as substantially equivalent to K022127 (Integra Lifesciences Corp., 2002) and 1 other predicate after a 70-day review. Its family tree reaches back 4 generations to 1988. 5 later devices descend from it. It has been recalled once.
- Decided
- Oct 10, 2007
- Review
- 70 days
- Class
- Class U
- Product code
- KGN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K881854 (1988). 10 ancestors in all. 5 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 3 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 2 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 1 generation backK022127 Avagen Wound DressingIntegra Lifesciences Corp. · 2002
- This deviceK072113 Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp. · 2007
- Descendant · cites it directly · 0 of its ownK250329 GeniPhys Collymer Self-Assembling ScaffoldGeniphys, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK134037 PremviaBiotime, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK110318 ExcellagenTissue Repair Company · 2011
- Descendant · cites it directly · 0 of its ownK102946 Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK081724 Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag…Applied Nutritionals · 2008
Most influential descendants
Showing 5 of 5 · See all- K250329GeniPhys Collymer Self-Assembling ScaffoldGeniphys, Inc. · 2025 · cites it directly0descendants
- K134037PremviaBiotime, Inc. · 2014 · cites it directly0descendants
- K110318ExcellagenTissue Repair Company · 2011 · cites it directly0descendants
- K102946Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd. · 2011 · cites it directly0descendants
- K081724Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan)…Applied Nutritionals · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −3 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −2 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −1 | K022127 | Avagen Wound Dressing | Integra Lifesciences Corp. | 2002 | — |
| 0 (this device) | K072113 | Integra Flowable Wound Matrix, Model FWD301 | Integra Lifesciences Corp. | 2007 | — |
| +1 | K250329 | GeniPhys Collymer Self-Assembling Scaffold | Geniphys, Inc. | 2025 | — |
| +1 | K134037 | Premvia | Biotime, Inc. | 2014 | — |
| +1 | K110318 | Excellagen | Tissue Repair Company | 2011 | — |
| +1 | K102946 | Coreleader Colla-Pad Model CS 03030 | Coreleader Biotech Co., Ltd. | 2011 | — |
| +1 | K081724 | Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated… | Applied Nutritionals | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K022127 | Avagen Wound DressingSummary page 1…t Code: KGN Substantial Equivalence: INTEGRATM Flowable Wound Matrix is substantially equivalent in function and intended use to INTEGRA TM Matrix Wound Dressing (K022127) and Medifil® Particles K910944. Device Description: INTEGRATM Flowable Wound Matrix is an advanced wound care device comprised o… | 2002 |
| * | K910944 | MedifilSummary page 1…quivalence: INTEGRATM Flowable Wound Matrix is substantially equivalent in function and intended use to INTEGRA TM Matrix Wound Dressing (K022127) and Medifil® Particles K910944. Device Description: INTEGRATM Flowable Wound Matrix is an advanced wound care device comprised of granulated cross-linked bovine… | 1991 |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2019 | Class II | Z-1338-2019 | Under Investigation by firm | Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K250329 (Geniphys, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K022127.
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. 2007, 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?
INTEGRATM Flowable Wound Matrix is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds. The device is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072113: Integra Flowable Wound Matrix, Model FWD301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072113
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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