510(k) · Cleared
ClearedCellusheet, Cellufil
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 Dec 15, 2021 as substantially equivalent to K122325 (Human Biosciences, Inc., 2012) and 2 other predicates after an 82-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Dec 15, 2021
- Review
- 82 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K913023 (1991). 4 ancestors in all, the oldest K910944 (1991). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K232758Comatryx OTCStrukmyer Medical, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913023 | Skintemp | Biocore | 1991 | — |
| −1 | K122325 | Skintemp II | Human Biosciences, Inc. | 2012 | — |
| 0 (this device) | K213092 | Cellusheet, Cellufil | Human Biosciences, Inc. | 2021 | — |
| +1 | K232758 | Comatryx OTC | Strukmyer Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K122325 | Skintemp IISummary page 4…ver-The-Counter Number Submission Name (OTC) Name 1 Device 1 K122325 SkinTemp II Dressing Cellusheet Dressing K925545… | 2012 |
| * | K910944 | MedifilSummary page 4…K913023 2 Device 2 K925545 Medifil II Particles Cellufil Particles K910944 Submission Type and Product Information Type of 510(k) submission: Special Device 1 Subject: Name of Device/Trade Name (OTC): C… | 1991 |
| * | K925545 | Skintemp, ModificationSummary page 4…) Name 1 Device 1 K122325 SkinTemp II Dressing Cellusheet Dressing K925545 K913023 2 Device 2 K925545 Medi… | 1993 |
| † | K081724 | Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan)… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232758 | Comatryx OTC | 2023 | 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?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 21.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K232758 (Strukmyer Medical, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122325.
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. 2021, 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 minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor bums.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213092: Cellusheet, Cellufil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213092
Report an extraction error
Are you the manufacturer?
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