510(k) · Cleared
ClearedSkintemp II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Human Biosciences, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Oct 26, 2012 as substantially equivalent to K913023 (Biocore, 1991) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.
- Decided
- Oct 26, 2012
- Review
- 86 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913023 (1991). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK913023 SkintempBiocore · 1991
- This deviceK122325 Skintemp IIHuman Biosciences, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK213092 Cellusheet, CellufilHuman Biosciences, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK253974 Roosin Collagen DressingRoosin Medical Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK232758 Comatryx OTCStrukmyer Medical, LLC · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913023 | Skintemp | Biocore | 1991 | — |
| 0 (this device) | K122325 | Skintemp II | Human Biosciences, Inc. | 2012 | — |
| +1 | K213092 | Cellusheet, Cellufil | Human Biosciences, Inc. | 2021 | — |
| +1 | K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | 2026 | — |
| +2 | K232758 | Comatryx OTC | Strukmyer Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K913023 | SkintempSummary page 3…=== 7.3 Product Materials o Collagen o Distilled water o Buffering agent (HBS proprietary name 'Chemical Z') 7.4 Predicate Device Biocore Inc. SkinTemp sheet (K913023 & K925545) 7.5 Summary of Technical Characteristics SkinTemp 11 Dressing is packaged as a low moisture hydrocolloid collagen w… | 1991 |
| * | K925545 | Skintemp, ModificationSummary page 3…oduct Materials o Collagen o Distilled water o Buffering agent (HBS proprietary name 'Chemical Z') 7.4 Predicate Device Biocore Inc. SkinTemp sheet (K913023 & K925545) 7.5 Summary of Technical Characteristics SkinTemp 11 Dressing is packaged as a low moisture hydrocolloid collagen wound dress… | 1993 |
What descends from it? (3)
2 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?
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. 2012, this device’s year, is highlighted.
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?
The device is intended for the management of bums, sores, blisters, scrapes, ulcers, and other wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122325: Skintemp II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122325
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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