510(k) · Cleared
ClearedPromogran Prisma™ Collagen Matrix with ORC and Silver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solventum Germany GmbH · FRO Dressing, Wound, Drug
Cleared on Mar 13, 2026 as substantially equivalent to K210135 (3M Healthcare Business Group, 2022) after a 259-day review. Its family tree reaches back 6 generations to 1988.
- Decided
- Mar 13, 2026
- Review
- 259 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K881854 (1988). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 5 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 4 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 3 generations backK021792 Bilayer Matrix Wound DressingIntegra Lifesciences Corp. · 2002 · Recalled
- 2 generations backK081635 Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp. · 2008
- 1 generation backK210135 PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix…3M Healthcare Business Group · 2022
- This deviceK251999 Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −5 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −4 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −3 | K021792 | Bilayer Matrix Wound Dressing | Integra Lifesciences Corp. | 2002 | 1 |
| −2 | K081635 | Integra Meshed Bilayer Wound Matrix | Integra Lifesciences Corp. | 2008 | — |
| −1 | K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing | 3M Healthcare Business Group | 2022 | — |
| 0 (this device) | K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large DressingSummary page 7…K251999 III. PREDICATE DEVICE Predicate Device Name: Promogran Prisma™ 510(k) number: K210135 Device Classification: Unclassified Product Code: FRO/OMP IV. DEVICE… | 2022 |
| † | K033523 | Collagen-Orc Antimicrobial Matrix | 2004 |
| † | K222859 | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place… | 2023 |
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 38 years and passes through 6 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Indications for use WITHOUT ActiV.A.C. Therapy System Promogran Prisma™ Collagen Matrix with ORC and Silver, when used without ActiV.A.C Negative Pressure Wound Therapy System, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ Collagen Matrix with ORC and Silver may be used for the management of: • Diabetic ulcers • Venous ulcers • Pressure ulcers • Ulcers caused by mixed vascular…
Read the full statement (375 words)
Indications for use WITHOUT ActiV.A.C. Therapy System
Promogran Prisma™ Collagen Matrix with ORC and Silver, when used without ActiV.A.C Negative Pressure Wound Therapy System, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ Collagen Matrix with ORC and Silver may be used for the management of:
• Diabetic ulcers
• Venous ulcers
• Pressure ulcers
• Ulcers caused by mixed vascular etiologies
• Full thickness and partial thickness wounds
• Donor sites and other bleeding surface wounds
• Abrasions
• Traumatic wounds healing by secondary Intention
• Dehisced surgical wounds
Promogran Prisma™ Collagen Matrix with ORC and Silver may be used under compression therapy with healthcare professional supervision.
Indications for Promogran Prisma™ Collagen Matrix with ORC and Silver when used in conjunction WITH the ActiV.A.C. Negative Pressure Wound Therapy System.
Promogran Prisma™ Collagen Matrix with ORC and Silver, when used with the ActiV.A.C. Negative Pressure Wound Therapy System, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ Collagen Matrix with ORC and Silver with the ActiV.A.C. Negative Pressure Wound Therapy System may be used for the management of:
• Venous ulcers
• Pressure ulcers
• Diabetic ulcers
• Partial-thickness burns
• Traumatic wounds healing by secondary intention
• Dehisced surgical wounds
Indications for Promogran Prisma™ Collagen Matrix with ORC and Silver, when used with V.A.C.® Peel and Place Dressings and the ActiV.A.C. Negative Pressure Therapy System.
Promogran Prisma™ Collagen Matrix with ORC and Silver, when used with the V.A.C.® Peel and Place Dressings and ActiV.A.C. Negative Pressure Wound Therapy System, is intended for the management of exuding wounds. Under the supervision of a health care professional, the V.A.C.® Peel and Place Dressing and ActiV.A.C. Negative Pressure Therapy System may be used for the management of:
• Venous ulcers
• Pressure ulcers
• Diabetic ulcers
• Partial-thickness burns
• Traumatic wounds healing by secondary intention
• Dehisced surgical wounds
Note: Compression therapy may only be used with Promogran Prisma™ Collagen Matrix with ORC and Silver under professional healthcare supervision. Compression therapy may not be used when Promogran Prisma™ Collagen Matrix with ORC and Silver is used with V.A.C.® Peel and Place Dressing and ActiV.A.C.™ Negative Pressure Wound Therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251999: Promogran Prisma™ Collagen Matrix with ORC and Silver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251999
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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