510(k) · Cleared
ClearedRENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Medical, Ltd. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Feb 18, 2025 as substantially equivalent to K142979 (Smith & Nephew, Inc., 2015) after a 91-day review. Its family tree reaches back 10 generations to 1995. 1 later device descends from it.
- Decided
- Feb 18, 2025
- Review
- 91 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K945062 (1995). 23 ancestors in all, the oldest K933902 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 6 generations between
- 3 generations backK102001 Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK132446 Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc. · 2013
- 1 generation backK142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound…Smith & Nephew, Inc. · 2015 · Recalled
- This deviceK243576 RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft…Smith & Nephew Medical, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK251826 RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 9 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 8 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 7 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 6 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 5 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 4 generations backK091470 Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · Recalled
- 3 generations backK102001 Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK132446 Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc. · 2013
- 1 generation backK142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound…Smith & Nephew, Inc. · 2015 · Recalled
- This deviceK243576 RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft…Smith & Nephew Medical, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −9 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −8 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −7 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −6 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −5 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −4 | K091470 | Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 | Smith & Nephew, Inc. | 2009 | 1 |
| −3 | K102001 | Modification to Renasys EZ Plus Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2010 | 3 |
| −2 | K132446 | Renasys EZ Max Negative Pressure Wound Therapy Device | Smith & Nephew, Inc. | 2013 | — |
| −1 | K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits… | Smith & Nephew, Inc. | 2015 | 1 |
| 0 (this device) | K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS… | Smith & Nephew Medical, Ltd. | 2025 | — |
| +1 | K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
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 |
|---|---|---|---|
| * | K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Summary page 5…lation 21 CFR 878.4780 Number Regulatory Class Class II Product Code OMP 21 CFR 807.92 (a)(3): Legally 510(k) Number: K142979 marketed device to Device Name: RENASYS Foam and Gauze NPWT Wound Dressing which equivalence Kits with Soft Port is c… | 2015 |
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 |
|---|---|---|---|
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | 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 30 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 23 ancestors have a recall of any class.
- Of its descendants, K251826 (Smith & Nephew Medical, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K142979.
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. 2025, 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 Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are intended to be used in conjunction with Smith + Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS system.
The Smith + Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and 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/K243576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243576: RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243576
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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