510(k) · Cleared
ClearedPROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Healthcare Business Group · FRO Dressing, Wound, Drug
Cleared on Feb 24, 2022 as substantially equivalent to K081635 (Integra Lifesciences Corp., 2008) after a 401-day review. Its family tree reaches back 5 generations to 1988. 1 later device descends from it.
- Decided
- Feb 24, 2022
- Review
- 401 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K881854 (1988). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 4 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 3 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 2 generations backK021792 Bilayer Matrix Wound DressingIntegra Lifesciences Corp. · 2002 · Recalled
- 1 generation backK081635 Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp. · 2008
- This deviceK210135 PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix…3M Healthcare Business Group · 2022
- Descendant · cites it directly · 0 of its ownK251999 Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH · 2026
Most influential descendants
Showing 1 of 1 · See all- K251999Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −4 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −3 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −2 | K021792 | Bilayer Matrix Wound Dressing | Integra Lifesciences Corp. | 2002 | 1 |
| −1 | K081635 | Integra Meshed Bilayer Wound Matrix | Integra Lifesciences Corp. | 2008 | — |
| 0 (this device) | K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing | 3M Healthcare Business Group | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K081635 | Integra Meshed Bilayer Wound MatrixSummary page 7…egally marketed device(s) to which equivalence is claimed [21 CFR 807.92(a)(3)] Integra™ Meshed Bilayer Wound Matrix (Integra LifeSciences Corp.), cleared under 510(k) K081635 for use with Negative Pressure Wound Therapy. Device description [21 CFR 807.92(a)(4)] 3M™ Promogran Prisma™ is comprised of… | 2008 |
| † | K033523 | Collagen-Orc Antimicrobial Matrix | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | 2026 | 0 |
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 34 years and passes through 5 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K251999 (Solventum Germany GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K081635.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Promogran Prisma™, when used without ActiV.A.C.™ Negative Pressure Wound Therapy, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ 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…
Read the full statement (173 words)
Promogran Prisma™, when used without ActiV.A.C.™ Negative Pressure Wound Therapy, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ 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.
Promogran Prisma™ when used with ActiV.A.C.™ Negative Pressure Wound Therapy is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ with ActiV.A.C.™ Negative Pressure Wound Therapy may be used only for the management of:
• Diabetic ulcers
• Venous ulcers
• Pressure ulcers
• Partial-thickness burns
• Traumatic wounds healing by secondary intention
• Dehisced surgical wounds.
Compression therapy may only be used with Promogran Prisma™ under professional healthcare supervision. Compression therapy may not be used when Promogran Prisma™ is used with ActiV.A.C.™ Negative Pressure Wound Therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210135: PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210135
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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