510(k) · Cleared
ClearedDermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Healthcare Business Group · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Sep 28, 2021 as substantially equivalent to K181505 (Kci USA, Inc., 2019) after a 64-day review. Its family tree reaches back 4 generations to 2010. 1 later device descends from it.
- Decided
- Sep 28, 2021
- Review
- 64 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K100821 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK100821 Prevena Incision Management SystemKci USA, Inc. · 2010 · Recalled
- 3 generations backK120033 Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit…Kci USA, Inc. · 2012
- 2 generations backK133276 V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round…Kci USA, Inc. · 2013
- 1 generation backK181505 V.A.C. DERMATAC DrapeKci USA, Inc. · 2019
- This deviceK212320 Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring…3M Healthcare Business Group · 2021
- Descendant · cites it directly · 0 of its ownK222859 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C.…3M · 2023
Most influential descendants
Showing 1 of 1 · See all- K2228593M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place…3M · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K100821 | Prevena Incision Management System | Kci USA, Inc. | 2010 | 8 |
| −3 | K120033 | Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac… | Kci USA, Inc. | 2012 | — |
| −2 | K133276 | V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing… | Kci USA, Inc. | 2013 | — |
| −1 | K181505 | V.A.C. DERMATAC Drape | Kci USA, Inc. | 2019 | — |
| 0 (this device) | K212320 | Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C.… | 3M Healthcare Business Group | 2021 | — |
| +1 | K222859 | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and… | 3M | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 OMP? 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 OMP device
- #1 K260646 Renasys Edge (66803126)score 15.3 · 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 |
|---|---|---|---|
| * | K181505 | V.A.C. DERMATAC DrapeSummary page 6…csimile: 210-255-6727 Date Prepared: 22 July 2021 Name of Subject Device: 3M™ DERMATAC™ Drape and V.A.C.® GRANUFOAM™ Dressing Predicate Device: V.A.C. DERMATAC™ Drape (K181505) Reference Device: RX4™ NPWT System, (V.A.C. Granufoam™ Dressing components of system) (K160487) Common or Usual Name: Dressing c… | 2019 |
| † | K160487 | V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System | 2016 |
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 |
|---|---|---|---|
| K222859 | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place… | 2023 | 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 11 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K222859 (3M, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181505.
How does its category compare?
All OMP devicesOMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OMP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMP
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMP
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMP
140in 2025
MAUDE reports naming product code OMP, 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 | 6 | 113 | 0 | 1 |
| 2008 | 8 | 98 | 0 | 1 |
| 2009 | 8 | 87 | 7 | 79 |
| 2010 | 6 | 97 | 3 | 80 |
| 2011 | 6 | 123 | 0 | 130 |
| 2012 | 11 | 292 | 1 | 97 |
| 2013 | 11 | 84 | 2 | 169 |
| 2014 | 10 | 179 | 4 | 229 |
| 2015 | 20 | 189 | 1 | 378 |
| 2016 | 19 | 146 | 2 | 398 |
| 2017 | 11 | 137 | 0 | 368 |
| 2018 | 13 | 214 | 0 | 422 |
| 2019 | 15 | 249 | 1 | 994 |
| 2020 | 6 | 179 | 0 | 3,664 |
| 2021 | 9 | 238 | 0 | 1,422 |
| 2022 | 10 | 229 | 0 | 258 |
| 2023 | 8 | 291 | 0 | 143 |
| 2024 | 9 | 181 | 2 | 135 |
| 2025 | 5 | 127 | 0 | 140 |
| 2026 | 9 | 141 | 0 | — |
What is it indicated for?
The Dermatac™ Drape and V.A.C. Granufoam™ Dressing are accessories to the: ACTIV.A.C.™ VAC. SIMPLICITY™ VA CVIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings. VACULTA™ INFOV.A.C.™ and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute care settings and other professional healthcare…
Read the full statement (190 words)
The Dermatac™ Drape and V.A.C. Granufoam™ Dressing are accessories to the:
ACTIV.A.C.™ VAC. SIMPLICITY™ VA CVIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings.
VACULTA™ INFOV.A.C.™ and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
When used on open wounds, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
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/K212320 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212320: Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212320
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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