510(k) · Cleared
Recalled · Class II · 2024Renasys Edge (66803126)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Medical Limited · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Nov 22, 2022 as substantially equivalent to K181822 (Smith & Nephew Medical Limited, 2019) after a 54-day review. Its family tree reaches back 12 generations to 1995. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 22, 2022
- Review
- 54 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 12 generations to K945062 (1995). 31 ancestors in all, the oldest K933902 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 8 generations between
- 3 generations backK142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound…Smith & Nephew, Inc. · 2015 · Recalled
- 2 generations backK143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB…Smith & Nephew, Inc. · 2015
- 1 generation backK181822 RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019
- This deviceK223041 Renasys Edge (66803126)Smith & Nephew Medical Limited · 2022
- Descendant · cites it directly · 1 of its ownK231939 Renasys EdgeSmith & Nephew Medical, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK260646 Renasys Edge (66803126)Smith & Nephew Medical, Ltd. · 2026
Show all 12 generations
- Root · 12 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 11 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 10 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 9 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 8 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 7 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 6 generations backK091470 Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · Recalled
- 5 generations backK102001 Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc. · 2010 · Recalled
- 4 generations backK132446 Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc. · 2013
- 3 generations backK142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound…Smith & Nephew, Inc. · 2015 · Recalled
- 2 generations backK143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB…Smith & Nephew, Inc. · 2015
- 1 generation backK181822 RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019
- This deviceK223041 Renasys Edge (66803126)Smith & Nephew Medical Limited · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −11 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −10 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −9 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −8 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −7 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −6 | K091470 | Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 | Smith & Nephew, Inc. | 2009 | 1 |
| −5 | K102001 | Modification to Renasys EZ Plus Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2010 | 3 |
| −4 | K132446 | Renasys EZ Max Negative Pressure Wound Therapy Device | Smith & Nephew, Inc. | 2013 | — |
| −3 | K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits… | Smith & Nephew, Inc. | 2015 | 1 |
| −2 | K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal… | Smith & Nephew, Inc. | 2015 | — |
| −1 | K181822 | RENASYS Touch; RENASYS Y-Connector | Smith & Nephew Medical Limited | 2019 | — |
| 0 (this device) | K223041 | Renasys Edge (66803126) | Smith & Nephew Medical Limited | 2022 | — |
| +1 | K231939 | Renasys Edge | Smith & Nephew Medical, Ltd. | 2024 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K181822 | RENASYS Touch; RENASYS Y-ConnectorSummary page 4…Number Regulatory Class Class II Product Code OMP 21 CFR 807.92 (a)(3): Legally 510(k) Number: K181822 marketed device to Device Name: RENASYS TOUCH which equivalence is claimed… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231939 | Renasys Edge | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2024 | Class II | Z-0516-2025 | Process control | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. |
| Mar 11, 2024 | Class II | Z-1596-2024 | Under Investigation by firm | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| Mar 11, 2024 | Class II | Z-1597-2024 | Under Investigation by firm | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 31 ancestors have a recall of any class.
- Of its descendants, K231939 (Smith & Nephew Medical, Ltd., 2024) has gone furthest, with 1 descendant of its own.
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. 2022, 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 RENASY'S EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing 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 When used with the RENASYS AB Abdominal Kit with Soft Port…
Read the full statement (149 words)
The RENASY'S EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing 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
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223041: Renasys Edge (66803126).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223041
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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