510(k) · Cleared
ClearedAcell Powder Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acell, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jun 23, 2006 as substantially equivalent to K021637 (Acell, Inc., 2002) and 1 other predicate after an 84-day review. Its family tree reaches back 6 generations to 1992. 5 later devices descend from it.
- Decided
- Jun 23, 2006
- Review
- 84 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921895 (1992). 27 ancestors in all, the oldest K830889 (1983). 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 3 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 2 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 1 generation backK021637 Acell Ubm Lyophilized Wound DressingAcell, Inc. · 2002
- This deviceK060888 Acell Powder Wound DressingAcell, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK172593 XCelliStem Wound PowderStemsys · 2018
- Descendant · cites it directly · 1 of its ownK080868 Aongen Collagen MatrixAeon Astron Europe B.V. · 2009
- Descendant · 2 generations on · 0 of its ownK232204 ReyaGel (RG03 - MTP gel 3mL)Fettech · 2024
- Descendant · 2 generations on · 0 of its ownK173223 ologen Collagen MatrixAeon Astron Europe B.V. · 2018
- Descendant · cites it directly · 0 of its ownK153754 MicroMatrixAcell, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K172593XCelliStem Wound PowderStemsys · 2018 · cites it directly1descendant
- K080868Aongen Collagen MatrixAeon Astron Europe B.V. · 2009 · cites it directly1descendant
- K232204ReyaGel (RG03 - MTP gel 3mL)Fettech · 2024 · 2 generations on0descendants
- K173223ologen Collagen MatrixAeon Astron Europe B.V. · 2018 · 2 generations on0descendants
- K153754MicroMatrixAcell, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −5 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −3 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −2 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K021637 | Acell Ubm Lyophilized Wound Dressing | Acell, Inc. | 2002 | — |
| 0 (this device) | K060888 | Acell Powder Wound Dressing | Acell, Inc. | 2006 | — |
| +1 | K172593 | XCelliStem Wound Powder | Stemsys | 2018 | — |
| +1 | K080868 | Aongen Collagen Matrix | Aeon Astron Europe B.V. | 2009 | — |
| +2 | K232204 | ReyaGel (RG03 - MTP gel 3mL) | Fettech | 2024 | — |
| +2 | K173223 | ologen Collagen Matrix | Aeon Astron Europe B.V. | 2018 | — |
| +1 | K153754 | MicroMatrix | Acell, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K021637 | Acell Ubm Lyophilized Wound DressingSummary page 1…on Number: Unclassified, Pre-amendment Classification Name: Dressing, Wound, Collagen Product Code: KGN Predicate Devices: K021637, ACeII, Inc., ACell UBM Lyophilized Wound Dressing K030921, Collagen Matrix, Inc., Collagen Topica… | 2002 |
| * | K030921 | Collagen Topical Wound DressingSummary page 1…nd, Collagen Product Code: KGN Predicate Devices: K021637, ACeII, Inc., ACell UBM Lyophilized Wound Dressing K030921, Collagen Matrix, Inc., Collagen Topical Wound Dressing Statement of Intended The ACellM Powder Wound Dressing is inten… | 2003 |
What descends from it? (5)
3 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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K172593 (Stemsys, 2018) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K021637.
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?
The ACell Powder Wound Dressing is intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060888 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060888: Acell Powder Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060888
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