510(k) · Cleared
ClearedHeliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram
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 Mar 31, 1999 after a 79-day review. The FDA summary names its predicate without a number. 85 later devices descend from it.
- Decided
- Mar 31, 1999
- Review
- 79 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 0
85 later devices descend from it, 8 citing it directly.
- This deviceK990086 Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 GramIntegra Lifesciences Corp. · 1999
- Descendant · cites it directly · 29 of its ownK030774 Stimulen CollagenSouthwest Technologies, Inc. · 2004 · Recalled
- Descendant · cites it directly · 28 of its ownK040283 BiopadEuroresearch Srl · 2005
- Descendant · cites it directly · 28 of its ownK030921 Collagen Topical Wound DressingCollagen Matrix, Inc. · 2003
- Descendant · 2 generations on · 26 of its ownK061494 Dermadapt Wound DressingPegasus Biologics, Inc. · 2006
- Descendant · 3 generations on · 25 of its ownK071425 Unite BiomatrixPegasus Biologics, Inc. · 2007
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K030774Stimulen CollagenSouthwest Technologies, Inc. · 2004 · cites it directly29descendants
- K040283BiopadEuroresearch Srl · 2005 · cites it directly28descendants
- K030921Collagen Topical Wound DressingCollagen Matrix, Inc. · 2003 · cites it directly28descendants
- K061494Dermadapt Wound DressingPegasus Biologics, Inc. · 2006 · 2 generations on26descendants
- K071425Unite BiomatrixPegasus Biologics, Inc. · 2007 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990086 | Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram | Integra Lifesciences Corp. | 1999 | — |
| +1 | K030774 | Stimulen Collagen | Southwest Technologies, Inc. | 2004 | 1 |
| +1 | K040283 | Biopad | Euroresearch Srl | 2005 | — |
| +1 | K030921 | Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2003 | — |
| +2 | K061494 | Dermadapt Wound Dressing | Pegasus Biologics, Inc. | 2006 | — |
| +3 | K071425 | Unite Biomatrix | Pegasus Biologics, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 9 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | hycure® Named without a submission number | |
| * | — | Fibracol Named without a submission number | |
| * | — | Kaltostat® Wound Packing Named without a submission number | |
| * | — | Chronicure Named without a submission number | |
| * | — | VitaChoice Named without a submission number |
What descends from it? (85)
See all 858 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030774 | Stimulen Collagen | 2004 | 29 |
| K040283 | Biopad | 2005 | 28 |
| K030921 | Collagen Topical Wound Dressing | 2003 | 28 |
| K061227 | Hydrolyzed Collagen/AG Wound Gel with Silver | 2006 | 21 |
| K090160 | Suprathel Wound and Burn Dressing | 2009 | 18 |
| K110318 | Excellagen | 2011 | 0 |
| K081724 | Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan)… | 2008 | 0 |
| K040314 | Healicoll | 2004 | 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?
- Of its descendants, K030774 (Southwest Technologies, Inc., 2004) has gone furthest, with 29 descendants of its own.
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.
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?
HeliDerm™ Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds, and to control minor bleeding.
HeliDerm™ may be used for the management of exudating wounds such as:
e PRESSURE ULCERS
e VENOUS STASIS ULCERS
e DIABETIC ULCERS
e ACUTE WOUNDS, for example trauma and surgical wounds
e PARTIAL-THICKNESS BURNS
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990086: Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990086
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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