510(k) Report

510(k) · Cleared

Cleared

Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan) Wound Gel

K081724510(k) TraditionalCleared Oct 30, 2008134-day reviewClass U

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

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

Cleared on Oct 30, 2008 as substantially equivalent to K955506 (The Hymed Group Corp., 1996) and 4 other predicates after a 134-day review. Its family tree reaches back 5 generations to 1988.

Decided
Oct 30, 2008
Review
134 days
Class
Class U
Product code
KGN
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K881854 (1988). 17 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestors1999: 1 other ancestor1996: 2 other ancestors1991: 3 other ancestors1990: 1 other ancestor1989: 1 other ancestor1998: 1 other ancestor1993: 1 other ancestorK881854 · Sorbsan Topical Wound Dressing · E.G. Dick & Assoc. · 1988K982597 · Fibrcol Plus Collagen Wound Dressing with Alginate · Johnson & Johnson Medical, Inc. · 1998K993948 · Sis Wound Dressing II · Cook Biotech, Inc. · 2000K022127 · Avagen Wound Dressing · Integra Lifesciences Corp. · 2002K072113 · Integra Flowable Wound Matrix, Model FWD301 · Integra Lifesciences Corp. · 2007 · recalled198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 4 other ancestors3 generations back: 2 other ancestors4 generations back: 2 other ancestors K072113 · Integra Flowable Wound Matrix, Model FWD301 · Integra Lifesciences Corp. · 2007 · recalledK022127 · Avagen Wound Dressing · Integra Lifesciences Corp. · 2002K993948 · Sis Wound Dressing II · Cook Biotech, Inc. · 2000K982597 · Fibrcol Plus Collagen Wound Dressing with Alginate · Johnson & Johnson Medical, Inc. · 1998K881854 · Sorbsan Topical Wound Dressing · E.G. Dick & Assoc. · 1988−50
  1. Root · 5 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
  2. 4 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
  3. 3 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
  4. 2 generations backK022127 Avagen Wound DressingIntegra Lifesciences Corp. · 2002
  5. 1 generation backK072113 Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp. · 2007 · Recalled
  6. This deviceK081724 Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag…Applied Nutritionals · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K881854Sorbsan Topical Wound DressingE.G. Dick & Assoc.1988—
−4K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc.1998—
−3K993948Sis Wound Dressing IICook Biotech, Inc.2000—
−2K022127Avagen Wound DressingIntegra Lifesciences Corp.2002—
−1K072113Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp.20071
0 (this device)K081724Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated…Applied Nutritionals2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199130
199310
199620
199810
199910
200220
FIG. 1 — Lineage of K081724, 1988–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

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
*K955506Hycure
Summary page 1
…* Identification of predicate devices to which substantial equivalence is being claimed: o HyCure® Hydrolyzed Collagen K955506 o HeliDerm TM Collagen Wound Dressing K990086 o Integra ® Bilayer Matrix Wound Dr…
The Hymed Group Corp.1996—
*K990086Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram
Summary page 1
…claimed: o HyCure® Hydrolyzed Collagen K955506 o HeliDerm TM Collagen Wound Dressing K990086 o Integra ® Bilayer Matrix Wound Dressing K021792 o Chondroprotec® (10% Polysulfated Glycosam…
Integra Lifesciences Corp.1999—
*K021792Bilayer Matrix Wound Dressing
Summary page 1
…K955506 o HeliDerm TM Collagen Wound Dressing K990086 o Integra ® Bilayer Matrix Wound Dressing K021792 o Chondroprotec® (10% Polysulfated GlycosaminoGlycan) K961930 o Integra® Flowable Wound Matrix…
Integra Lifesciences Corp.20021
*K961930Chondroprotec
Summary page 1
…K990086 o Integra ® Bilayer Matrix Wound Dressing K021792 o Chondroprotec® (10% Polysulfated GlycosaminoGlycan) K961930 o Integra® Flowable Wound Matrix K072113 Description of the Device: Hydrolyzed Collagen with…
The Hymed Group Corp.1996—
*K072113Integra Flowable Wound Matrix, Model FWD301
Summary page 1
…Dressing K021792 o Chondroprotec® (10% Polysulfated GlycosaminoGlycan) K961930 o Integra® Flowable Wound Matrix K072113 Description of the Device: Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound…
Integra Lifesciences Corp.20071

Also cleared against K955506: 3 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?

  • The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 17 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K955506.

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. 2008, this device’s year, is highlighted.

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?

Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound gel is indicated for topical use in the management of chronic and acute wounds and dermal ulcers including the local management of:

* Pressure Ulcers (Stage I-IV)

* Venous Stasis Ulcers

* Diabetic Ulcers

* First and Second Degree Burns

* Surgical wounds

* Traumatic wounds

* Superficial wounds

* Ulcers resulting from arterial insufficiency

* Grafted wounds and donor sites

For over the counter use, Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel may be used for:

- minor abrasions

- lacerations

- minor cuts

- minor scalds and burns

Indications for use as stated in the FDA summary.

Also cleared against K955506

3 other devices cite the same predicate.

  • K110318ExcellagenTissue Repair Company · 2011
  • K061227Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2006
  • K030774Stimulen CollagenSouthwest Technologies, Inc. · 20041 recall

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/K081724 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081724: Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan) Wound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081724

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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