510(k) · Cleared
ClearedHycure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Hymed Group Corp. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jan 17, 1996 after a 47-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 53 later devices descend from it.
- Decided
- Jan 17, 1996
- Review
- 47 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 0
53 later devices descend from it, 4 citing it directly.
- This deviceK955506 HycureThe Hymed Group Corp. · 1996
- Descendant · cites it directly · 29 of its ownK030774 Stimulen CollagenSouthwest Technologies, Inc. · 2004 · Recalled
- 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
- Descendant · cites it directly · 21 of its ownK061227 Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2006
- Descendant · 4 generations on · 19 of its ownK092096 Endoform Dermal TemplateMesynthes, Ltd. · 2010 · Recalled
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K030774Stimulen CollagenSouthwest Technologies, Inc. · 2004 · cites it directly29descendants
- K061494Dermadapt Wound DressingPegasus Biologics, Inc. · 2006 · 2 generations on26descendants
- K071425Unite BiomatrixPegasus Biologics, Inc. · 2007 · 3 generations on25descendants
- K061227Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2006 · cites it directly21descendants
- K092096Endoform Dermal TemplateMesynthes, Ltd. · 2010 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955506 | Hycure | The Hymed Group Corp. | 1996 | — |
| +1 | K030774 | Stimulen Collagen | Southwest Technologies, Inc. | 2004 | 1 |
| +2 | K061494 | Dermadapt Wound Dressing | Pegasus Biologics, Inc. | 2006 | — |
| +3 | K071425 | Unite Biomatrix | Pegasus Biologics, Inc. | 2007 | — |
| +1 | K061227 | Hydrolyzed Collagen/AG Wound Gel with Silver | The Hymed Group Corp. | 2006 | — |
| +4 | K092096 | Endoform Dermal Template | Mesynthes, Ltd. | 2010 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (53)
See all 534 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)
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 | — |
https://510kreport.com/device/K955506 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955506: Hycure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955506
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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