510(k) · Cleared
ClearedRenasys Edge (66803126)
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 May 27, 2026 as substantially equivalent to K231939 (Smith & Nephew Medical, Ltd., 2024) after an 89-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- May 27, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K945062 (1995). 33 ancestors in all, the oldest K933902 (1994). No later device cites it as a predicate yet.
- Root · 14 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 10 generations between
- 3 generations backK181822 RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019
- 2 generations backK223041 Renasys Edge (66803126)Smith & Nephew Medical Limited · 2022 · Recalled
- 1 generation backK231939 Renasys EdgeSmith & Nephew Medical, Ltd. · 2024
- This deviceK260646 Renasys Edge (66803126)Smith & Nephew Medical, Ltd. · 2026
Show all 14 generations
- Root · 14 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 13 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 12 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 11 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 10 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 9 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 8 generations backK091470 Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · Recalled
- 7 generations backK102001 Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc. · 2010 · Recalled
- 6 generations backK132446 Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc. · 2013
- 5 generations backK142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound…Smith & Nephew, Inc. · 2015 · Recalled
- 4 generations backK143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB…Smith & Nephew, Inc. · 2015
- 3 generations backK181822 RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019
- 2 generations backK223041 Renasys Edge (66803126)Smith & Nephew Medical Limited · 2022 · Recalled
- 1 generation backK231939 Renasys EdgeSmith & Nephew Medical, Ltd. · 2024
- This deviceK260646 Renasys Edge (66803126)Smith & Nephew Medical, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −13 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −12 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −11 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −10 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −9 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −8 | K091470 | Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 | Smith & Nephew, Inc. | 2009 | 1 |
| −7 | K102001 | Modification to Renasys EZ Plus Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2010 | 3 |
| −6 | K132446 | Renasys EZ Max Negative Pressure Wound Therapy Device | Smith & Nephew, Inc. | 2013 | — |
| −5 | K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits… | Smith & Nephew, Inc. | 2015 | 1 |
| −4 | K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal… | Smith & Nephew, Inc. | 2015 | — |
| −3 | K181822 | RENASYS Touch; RENASYS Y-Connector | Smith & Nephew Medical Limited | 2019 | — |
| −2 | K223041 | Renasys Edge (66803126) | Smith & Nephew Medical Limited | 2022 | 3 |
| −1 | K231939 | Renasys Edge | Smith & Nephew Medical, Ltd. | 2024 | — |
| 0 (this device) | K260646 | Renasys Edge (66803126) | Smith & Nephew Medical, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 K243576 RENASYS Foam Wound Dressing Kit with AIRLOCK…score 14.6 · 10 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 |
|---|---|---|---|
| * | K231939 | Renasys EdgeSummary page 6…Product Code OMP 21 CFR 807.92 (a)(3): Legally marketed device to which equivalence is claimed 510(k) Number K231939 Device Name RENASYSTM EDGE 21 CFR 807.92 (a)(4): Device Description The… | 2024 |
| † | K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | 2025 |
| † | K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze… | 2025 |
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 31 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 15 of the 33 ancestors have a recall of any class.
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. 2026, 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™ EDGE Pump is indicated for patients who would benefit from a suction pump (NPWT), as it allows for wound management via removal of fluids, including irrigation fluids and body fluids, wound exudate 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 The RENASYS™ EDGE Pump is compatible with…
Read the full statement (245 words)
The RENASYS™ EDGE Pump is indicated for patients who would benefit from a suction pump (NPWT), as it allows for wound management via removal of fluids, including irrigation fluids and body fluids, wound exudate 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
The RENASYS™ EDGE Pump is compatible with the following:
• RENASYS™ Foam Dressing Kits
• RENASYS™ Foam Dressing Kit - XL
• RENASYS™ Gauze Dressing Kits
• RENASYS™ Abdominal Dressing Kit
• RENASYS™ Y Connector Kit
• RENASYS™ White Foam Wound Dressing
• RENASYS™ WOUND+ Dressing Kit with AIRLOCK Technology
When used with the RENASYS™ WOUND+ Dressing Kit without filler, the RENASYS™ EDGE pump is indicated for the following additional wound type:
• Closed surgical incisions
Important information when using the RENASYS™ AB Abdominal Kit with Soft Port.
When used with the RENASYS™ AB Abdominal Kit with Soft Port, the RENASYS™ EDGE Pump is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS™ AB Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260646: Renasys Edge (66803126).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260646
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026