510(k) Report

510(k) · Cleared

Cleared

Medifil

K910944510(k) TraditionalCleared Apr 2, 199127-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biocore · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Apr 2, 1991 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 267 later devices descend from it.

Decided
Apr 2, 1991
Review
27 days
Class
Class U
Product code
KGN
Recalls
None
Predicates
0

267 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2021: 9 descendants cleared2004: 8 descendants cleared2007: 12 descendants cleared1996: 1 descendant cleared2013: 10 descendants cleared2006: 10 descendants cleared2000: 2 descendants cleared2011: 15 descendants cleared2003: 5 descendants cleared2026: 14 descendants cleared2022: 12 descendants cleared2009: 13 descendants cleared2014: 12 descendants cleared2025: 16 descendants cleared2008: 13 descendants cleared2023: 10 descendants cleared2002: 7 descendants cleared2010: 14 descendants cleared2005: 3 descendants cleared2015: 8 descendants cleared2020: 3 descendants cleared2012: 14 descendants cleared2024: 15 descendants cleared2018: 9 descendants cleared2016: 10 descendants cleared2017: 16 descendants cleared2019: 6 descendants cleared1990200020102020
  1. This deviceK910944 MedifilBiocore · 1991
  2. Descendant · cites it directly · 235 of its ownK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
  3. Descendant · 2 generations on · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  4. Descendant · 3 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
  5. Descendant · 3 generations on · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003
  6. Descendant · 4 generations on · 72 of its ownK042809 CuffpatchOrganogenesis, Inc. · 2004

Showing 5 of 267 descendants. See all descendants

Descendants cleared per year

1996: 12000: 22002: 72003: 52004: 82005: 32006: 102007: 122008: 132009: 132010: 142011: 152012: 142013: 102014: 122015: 82016: 102017: 162018: 92019: 62020: 32021: 92022: 122023: 102024: 152025: 162026: 14
1996high 16 (2017) · low 0 (1997)2026

Most influential descendants

Showing 5 of 267 · See all
  • K993948Sis Wound Dressing IICook Biotech, Inc. · 2000 · cites it directly235descendants
  • K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · 2 generations on173descendants
  • K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 3 generations on102descendants
  • K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · 3 generations on91descendants
  • K042809CuffpatchOrganogenesis, Inc. · 2004 · 4 generations on72descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910944MedifilBiocore1991—
+1K993948Sis Wound Dressing IICook Biotech, Inc.2000—
+2K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
+3K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002—
+3K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2003—
+4K042809CuffpatchOrganogenesis, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200020
200270
200350
200480
200530
2006100
2007120
2008130
2009130
2010140
2011150
2012140
2013100
2014120
201580
2016100
2017160
201890
201960
202030
202190
2022120
2023100
2024150
2025160
2026140
FIG. 1 — Lineage of K910944, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (267)

See all 267

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993948Sis Wound Dressing IICook Biotech, Inc.2000235
K030774Stimulen CollagenSouthwest Technologies, Inc.200429
K030921Collagen Topical Wound DressingCollagen Matrix, Inc.200328
K072113Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp.20075
K061474Collawound DressingCollamatrix Co., Inc.20063
K213092Cellusheet, CellufilHuman Biosciences, Inc.20211
K120250Fibrillar Collagen Wound DressingCollafirm, LLC20130
K110318ExcellagenTissue Repair Company20110
K040314HealicollEncoll Corp.20040
K963228Repliderm Wound DressingOrphan Medical, Inc.19960

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?

  • Of its descendants, K993948 (Cook Biotech, Inc., 2000) has gone furthest, with 235 descendants of its own.

How does its category compare?

All KGN devices

KGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGN

15so far in 2026, the most since 2007

2007: 32008: 62009: 82010: 42011: 72012: 82013: 62014: 52015: 72016: 42017: 72018: 62019: 32020: 52021: 62022: 122023: 92024: 132025: 102026 (partial year): 15
2007high 15 (2026) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGN

162in 2025

2007: 32 days median2008: 87 days median2009: 121 days median2010: 175 days median2011: 228 days median2012: 123 days median2013: 147 days median2014: 188 days median2015: 87 days median2016: 164 days median2017: 136 days median2018: 148 days median2019: 128 days median2020: 279 days median2021: 236 days median2022: 246 days median2023: 194 days median2024: 83 days median2025: 162 days median2026 (partial year): 174 days median
2007high 279 (2020) · low 32 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGN

3in 2018

2017: 12018: 3
2007high 3 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGN

15in 2025

2008: 12009: 22010: 32011: 62012: 42013: 62014: 122015: 92016: 62017: 82018: 152019: 112020: 172021: 142022: 132023: 212024: 152025: 15
2007high 21 (2023) · low 0 (2007)2025

MAUDE reports naming product code KGN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200733200
200868701
2009812102
2010417503
2011722806
2012812304
2013614706
20145188012
201578709
2016416406
2017713618
20186148315
20193128011
20205279017
20216236014
202212246013
20239194021
20241383015
202510162015
2026151740—

More from Biocore

3 FDA decisions under this applicant name. See the company

  • K925545Skintemp, ModificationBiocore · 1993
  • K913023SkintempBiocore · 1991

Recent decisions in KGN

The KGN category page

  • K260920Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc…Berkeley Advanced Biomaterials · 2026
  • K260530epi-ConneKt™ Wound MatrixMLM Biologics, Inc. · 2026
  • K260652ColActive PlusCovalon Technologies, Ltd. · 2026
  • K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus…Berkeley Advanced Biomaterials · 2026
  • K260596Collagen Wound PowderVentris Medical · 2026

https://510kreport.com/device/K910944 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910944: Medifil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910944

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026