510(k) · Cleared
ClearedOmeza Collagen Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omeza, LLC · FRO Dressing, Wound, Drug
Cleared on Sep 1, 2021 as substantially equivalent to K182725 (Sweetbio, Inc., 2019) after a 69-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Sep 1, 2021
- Review
- 69 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K881854 (1988). 17 ancestors in all, the oldest K872165 (1987). 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 backK090812 Theraform Standard/SheetSewon Cellontech Co., Ltd. · 2009
- 2 generations backK112580 Collagen Wound DressingDalim Tissen Co., Ltd. · 2012
- 1 generation backK182725 ApisSweetbio, Inc. · 2019
- This deviceK211972 Omeza Collagen MatrixOmeza, LLC · 2021
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 | K090812 | Theraform Standard/Sheet | Sewon Cellontech Co., Ltd. | 2009 | — |
| −2 | K112580 | Collagen Wound Dressing | Dalim Tissen Co., Ltd. | 2012 | — |
| −1 | K182725 | Apis | Sweetbio, Inc. | 2019 | — |
| 0 (this device) | K211972 | Omeza Collagen Matrix | Omeza, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 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 |
|---|---|---|---|
| * | K182725 | ApisSummary page 4…Dressing, Wound, Drug Regulatory Classification: Unclassified Product Code: FRO Predicate Device: SweetBio Apis (K182725) Reference Devices: INTEGRATM Flowable Wound Matrix (K072113) Kerecis MariGen Wound Dressing (K132… | 2019 |
| † | K072113 | Integra Flowable Wound Matrix, Model FWD301 | 2007 |
| † | K132343 | Marigen Wound Dressing | 2013 |
| † | K030774 | Stimulen Collagen | 2004 |
| † | K092096 | Endoform Dermal Template | 2010 |
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 33 years and passes through 8 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K182725.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
Omeza® Collagen Matrix is indicated for the management of 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, superficial partial thickness burns, skin tears)
• Draining wounds
The device is intended for one-time use.
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/K211972 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211972: Omeza Collagen Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211972
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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