510(k) · Cleared
ClearedRENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply
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 Aug 4, 2016 as substantially equivalent to K142979 (Smith & Nephew, Inc., 2015) and 1 other predicate after a 273-day review. Its family tree reaches back 10 generations to 1995. 5 later devices descend from it.
- Decided
- Aug 4, 2016
- Review
- 273 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K945062 (1995). 24 ancestors in all, the oldest K933902 (1994). 5 later devices descend from it, 2 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 deviceK153209 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH…Smith & Nephew Medical, Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK181822 RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019
- Descendant · 2 generations on · 2 of its ownK223041 Renasys Edge (66803126)Smith & Nephew Medical Limited · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK231939 Renasys EdgeSmith & Nephew Medical, Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK260646 Renasys Edge (66803126)Smith & Nephew Medical, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK181204 RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited · 2019
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 deviceK153209 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH…Smith & Nephew Medical, Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019 · cites it directly3descendants
- K223041Renasys Edge (66803126)Smith & Nephew Medical Limited · 2022 · 2 generations on2descendants
- K231939Renasys EdgeSmith & Nephew Medical, Ltd. · 2024 · 3 generations on1descendant
- K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd. · 2026 · 4 generations on0descendants
- K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited · 2019 · 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) | K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters… | Smith & Nephew Medical, Ltd. | 2016 | — |
| +1 | K181822 | RENASYS Touch; RENASYS Y-Connector | Smith & Nephew Medical Limited | 2019 | — |
| +2 | K223041 | Renasys Edge (66803126) | Smith & Nephew Medical Limited | 2022 | 3 |
| +3 | K231939 | Renasys Edge | Smith & Nephew Medical, Ltd. | 2024 | — |
| +4 | K260646 | Renasys Edge (66803126) | Smith & Nephew Medical, Ltd. | 2026 | — |
| +1 | K181204 | RENASYS Y-Connector; RENASYS TOUCH | Smith & Nephew Medical Limited | 2019 | — |
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 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 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? (2)
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 4…Date RENASYS TOUCH RENASYS EZ MAX Negative Negative Pressure Wound Pressure Wound Therapy K142979 04/29/2015 Therapy Device Device (Primary Predicate) Invia Liberty Negative Pressure RENASY… | 2015 |
| * | K142626 | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set…Summary page 4…rapy Device Device (Primary Predicate) Invia Liberty Negative Pressure RENASYS Y-Connector K142626 06/12/2015 Wound Therapy System… | 2015 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 24 ancestors have a recall of any class.
- Of its descendants, K181822 (Smith & Nephew Medical Limited, 2019) has gone furthest, with 3 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. 2016, 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?
RENASYS TOUCH is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it may promote wound healing 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 and grafts
The RENASYS TOUCH is intended 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153209: RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153209
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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