510(k) Report

510(k) · Cleared

Cleared

Repliderm Wound Dressing

K963228510(k) TraditionalCleared Dec 18, 1996121-day reviewClass U

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

Orphan Medical, Inc. · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Dec 18, 1996 as substantially equivalent to K910944 (Biocore, 1991) and 4 other predicates after a 121-day review. Its family tree reaches back 1 generation to 1984.

Decided
Dec 18, 1996
Review
121 days
Class
Class U
Product code
KGN
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K834343 (1984). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 2 other ancestors1991: 1 other ancestor1990: 1 other ancestorK834343 · Comfeel Powder · Coloplast A/S · 19841980198519901995
Other ancestors, by generation 1 generation back: 4 other ancestors K834343 · Comfeel Powder · Coloplast A/S · 19840
  1. Root · 1 generation backK834343 Comfeel PowderColoplast A/S · 1984
  2. This deviceK963228 Repliderm Wound DressingOrphan Medical, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K834343Comfeel PowderColoplast A/S1984—
0 (this device)K963228Repliderm Wound DressingOrphan Medical, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199110
199220
FIG. 1 — Lineage of K963228, 1984–1996Source: 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), 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. #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
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What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K910944Medifil
Summary page 3
…characteristics. S. Substantial equivalency Repliderm™ Wound Dressing consists mainly of collagen powder, similar to Kollagen™ (Medifil™) particles from BioCore Inc.™ (K910944) and other collagen-based wound healing products in commercial distribution. Repliderm™ Wound Dressing can be used to absorb wou…
Biocore1991—
*K902345Carrington Wound Dressing
Summary page 3
…escribed use of Kollagen™ powder. Repliderm™ Wound Dressing can also be used as a wound dressing, similar to Carrasyn™ Hydrogel wound dressing (Carrington Laboratories, K902345) and Comfeel® hydrogel powder (Coloplast Sween Corp., K834343). Repliderm™ Wound Dressing is similar to the hydrogel wound dress…
Carrington Laboratories, Inc.1990—
*K920642Micro-Coll Collagen Dermal Wound Spray
Summary page 3
…de Kollagen™ (Medifil™) particles (BioCore Inc., K910944), Carrasyn™ Hydrogel wound dressing (Carrington Laboratories, K902345), Micro-Coll™ Collagen Dermal Wound Spray (K920642), Micro- Coll™ Collagen Wound Spray (K912565), and Comfeel® hydrogel powder (Coloplast Sween Corp., K834343). 6. Safety and Eff…
Micro-Collagen Pharmaceutics, Ltd.1992—
*K912565Micro-Coll Collagen Wound Spray
Summary page 3
…., K910944), Carrasyn™ Hydrogel wound dressing (Carrington Laboratories, K902345), Micro-Coll™ Collagen Dermal Wound Spray (K920642), Micro- Coll™ Collagen Wound Spray (K912565), and Comfeel® hydrogel powder (Coloplast Sween Corp., K834343). 6. Safety and Efficacy: The safety and efficacy of Repliderm™…
Micro-Coll1992—
*K834343Comfeel Powder
Summary page 3
…an also be used as a wound dressing, similar to Carrasyn™ Hydrogel wound dressing (Carrington Laboratories, K902345) and Comfeel® hydrogel powder (Coloplast Sween Corp., K834343). Repliderm™ Wound Dressing is similar to the hydrogel wound dressings approved for commercial distribution, since it is derived…
Coloplast A/S1984—

Also cleared against K910944: 9 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 5 ancestors has a recall.
  • 9 other devices also cite its predicate K910944.

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—

What is it indicated for?

Repliderm™ Wound Dressing cartilage powder is a collagen based powder intended for use in the management of pressure ulcers (stages I - IV), stasis ulcers, 1st and 2nd degree burns, diabetic ulcers, foot ulcers, post surgical incisions, radiation dermatitis, cuts, abrasions, irritations of the skin, partial thickness wounds and skin conditions associated with peristomal care.

Repliderm™ Wound Dressing has also been shown to be useful for wound exudate absorption.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K910944

9 other devices cite the same predicate.

  • K213092Cellusheet, CellufilHuman Biosciences, Inc. · 2021
  • K120250Fibrillar Collagen Wound DressingCollafirm, LLC · 2013
  • K110318ExcellagenTissue Repair Company · 2011
  • K072113Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp. · 20071 recall
  • K061474Collawound DressingCollamatrix Co., Inc. · 2006
  • K040314HealicollEncoll Corp. · 2004

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/K963228 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963228: Repliderm Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963228

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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