510(k) · Cleared
ClearedRENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith and Nephew Medical Limited · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Feb 10, 2023 as substantially equivalent to K133276 (Kci USA, Inc., 2013) after a 427-day review. Its family tree reaches back 3 generations to 2010. 1 later device descends from it.
- Decided
- Feb 10, 2023
- Review
- 427 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K100821 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK100821 Prevena Incision Management SystemKci USA, Inc. · 2010 · Recalled
- 2 generations backK120033 Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit…Kci USA, Inc. · 2012
- 1 generation backK133276 V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round…Kci USA, Inc. · 2013
- This deviceK213853 RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam…Smith and Nephew Medical Limited · 2023
- Descendant · cites it directly · 0 of its ownK250586 Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits…Deroyal Industries, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…Deroyal Industries, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K100821 | Prevena Incision Management System | Kci USA, Inc. | 2010 | 8 |
| −2 | K120033 | Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac… | Kci USA, Inc. | 2012 | — |
| −1 | K133276 | V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing… | Kci USA, Inc. | 2013 | — |
| 0 (this device) | K213853 | RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT… | Smith and Nephew Medical Limited | 2023 | — |
| +1 | K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White… | Deroyal Industries, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K133276 | V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam…Summary page 4…780 Regulatory Class Class II Product Code OMP 21 CFR 807.92 (a)(3): 510(k) Number: K133276 Legally marketed device to Device Name: V.A.C.® Negative Pressure Wound Therapy System,… | 2013 |
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 |
|---|---|---|---|
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam… | 2025 | 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 13 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K250586 (Deroyal Industries, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K133276.
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. 2023, 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 RENASYS White Foam NPWT Dressing is a moist, sterile, polyvinyl alcohol (PVA) foam intended to be used in conjunction with Smith & Nephew RENASYS TOUCH and RENASYS GO Negative Pressure Wound Therapy (NPWT) Systems.
The Smith & Nephew RENASYS system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy) as it may promote wound healing via the removal of wound fluids, including irrigation of body fluids, wound exudates and infectious materials.
Appropriate wound types include:
• Chronic
• Acute
• Traumatic
• Sub-Acute and dehisced wounds
• Ulcers (such as pressure or diabetic)
• Partial-thickness burns
• Flaps
• Grafts
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213853: RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213853
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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