510(k) · Cleared
ClearedCollagen-Orc Antimicrobial Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Medical, Ltd. · FRO Dressing, Wound, Drug
Cleared on Oct 21, 2004 as substantially equivalent to K014129 (Johnson & Johnson Medical, Ltd., 2002) and 1 other predicate after a 349-day review. Its family tree reaches back 3 generations to 1988. 4 later devices descend from it.
- Decided
- Oct 21, 2004
- Review
- 349 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K881854 (1988). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 2 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 1 generation backK014129 Promogran Matrix Wound DressingJohnson & Johnson Medical, Ltd. · 2002
- This deviceK033523 Collagen-Orc Antimicrobial MatrixJohnson & Johnson Medical, Ltd. · 2004
- Descendant · cites it directly · 3 of its ownK080949 Keratec Wound DressingsKeratec Limited · 2009
- Descendant · 2 generations on · 1 of its ownK162759 KeraStat (R) GelKeranetics, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK192386 KeraStat CreamKeranetics · 2020
- Descendant · 2 generations on · 0 of its ownK182010 ProgenaMatrixCell Constructs I, LLC · 2019 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K080949Keratec Wound DressingsKeratec Limited · 2009 · cites it directly3descendants
- K162759KeraStat (R) GelKeranetics, LLC · 2017 · 2 generations on1descendant
- K192386KeraStat CreamKeranetics · 2020 · 3 generations on0descendants
- K182010ProgenaMatrixCell Constructs I, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −2 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −1 | K014129 | Promogran Matrix Wound Dressing | Johnson & Johnson Medical, Ltd. | 2002 | — |
| 0 (this device) | K033523 | Collagen-Orc Antimicrobial Matrix | Johnson & Johnson Medical, Ltd. | 2004 | — |
| +1 | K080949 | Keratec Wound Dressings | Keratec Limited | 2009 | — |
| +2 | K162759 | KeraStat (R) Gel | Keranetics, LLC | 2017 | — |
| +3 | K192386 | KeraStat Cream | Keranetics | 2020 | — |
| +2 | K182010 | ProgenaMatrix | Cell Constructs I, LLC | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (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.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080949 | Keratec Wound Dressings | 2009 | 3 |
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 16 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K080949 (Keratec Limited, 2009) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K014129.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Collagen-ORC Antimicrobial Matrix is intended for the management of exuding wounds.
Under the supervision of a health care professional, Collagen-ORC Antimicrobial Matrix may be used for the management of:
Diabetic ulcers
Venous ulcers
Pressure ulcers
Ulcers caused by mixed vascular etiologies
Full-thickness & partial thickness wounds
Donor sites and other bleeding surface wounds
Abrasions
Traumatic wounds healing by secondary intention
Dehisced surgical wounds
Collagen-ORC Antimicrobial Matrix may be used under compression therapy with healthcare professional supervision,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033523: Collagen-Orc Antimicrobial Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033523
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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