510(k) · Cleared
ClearedHelios Dermal Scaffold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helios Biomedical, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Aug 15, 2025 as substantially equivalent to K153690 (Tei Biosciences, Inc., 2016) after a 184-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Aug 15, 2025
- Review
- 184 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K881854 (1988). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 7 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 6 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 5 generations backK023778 DressskinTei Biosciences, Inc. · 2003
- 4 generations backK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- 3 generations backK083440 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
- 2 generations backK131286 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2013
- 1 generation backK153690 PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2016 · Recalled
- This deviceK250397 Helios Dermal ScaffoldHelios Biomedical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −7 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −6 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −5 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| −4 | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| −3 | K083440 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2008 | — |
| −2 | K131286 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2013 | — |
| −1 | K153690 | PriMatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2016 | 4 |
| 0 (this device) | K250397 | Helios Dermal Scaffold | Helios Biomedical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 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? (1)
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 |
|---|---|---|---|
| * | K153690 | PriMatrix Dermal Repair ScaffoldSummary page 5…General & Plastic Surgery III. Predicate Device Substantial equivalence is claimed to the following device: ● PriMatrix™ Dermal Repair Scaffold (“PriMatrix”), K153690, Integra Lifesciences Corp/TEI Biosciences. The following devices are cited as reference devices within the submission:… | 2016 |
| † | K210331 | CardiaMend Pericardial and Epicardial Reconstruction Matrix | 2021 |
| † | K071807 | Orthomend Soft Tissue Matrix | 2007 |
| † | K161370 | Durepair Dura Regeneration Matrix | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 1 other device also cites its predicate K153690.
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. 2025, 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?
Helios Dermal Scaffold is intended for the management of wounds that include:
Partial- and full- thickness wounds
Pressure, diabetic, and venous ulcers
Partial thickness burns
Surgical wounds — donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence
Trauma wounds — abrasions, lacerations and skin tears
Tunneled/undermined wounds
Draining wounds
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/K250397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250397: Helios Dermal Scaffold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250397
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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