510(k) · Cleared
ClearedRenasys EZ Max Negative Pressure Wound Therapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Oct 23, 2013 as substantially equivalent to K102001 (Smith & Nephew, Inc., 2010) after a 78-day review. Its family tree reaches back 8 generations to 1995. 13 later devices descend from it.
- Decided
- Oct 23, 2013
- Review
- 78 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945062 (1995). 19 ancestors in all, the oldest K933902 (1994). 13 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 7 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 6 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 5 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 4 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 3 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 2 generations backK091470 Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · Recalled
- 1 generation backK102001 Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc. · 2010 · Recalled
- This deviceK132446 Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc. · 2013
- Descendant · cites it directly · 12 of its ownK142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound…Smith & Nephew, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 5 of its ownK153209 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH…Smith & Nephew Medical, Ltd. · 2016
- Descendant · cites it directly · 5 of its ownK143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB…Smith & Nephew, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK181822 RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019
- Descendant · 3 generations on · 2 of its ownK223041 Renasys Edge (66803126)Smith & Nephew Medical Limited · 2022 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc. · 2015 · cites it directly12descendants
- K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd. · 2016 · 2 generations on5descendants
- K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc. · 2015 · cites it directly5descendants
- K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019 · 2 generations on3descendants
- K223041Renasys Edge (66803126)Smith & Nephew Medical Limited · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −7 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −6 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −5 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −4 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −3 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −2 | K091470 | Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 | Smith & Nephew, Inc. | 2009 | 1 |
| −1 | K102001 | Modification to Renasys EZ Plus Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2010 | 3 |
| 0 (this device) | 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 |
| +2 | K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters… | Smith & Nephew Medical, Ltd. | 2016 | — |
| +1 | K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal… | Smith & Nephew, Inc. | 2015 | — |
| +2 | K181822 | RENASYS Touch; RENASYS Y-Connector | Smith & Nephew Medical Limited | 2019 | — |
| +3 | K223041 | Renasys Edge (66803126) | Smith & Nephew Medical Limited | 2022 | 3 |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K102001 | Modification to Renasys EZ Plus Negative Pressure Wound TherapySummary page 1…Product Code: OMP Predicate Device Information 510(k) # Device Clearance Date IK102001 RENASYS EZ PLUS 108/06/2010 Device Description The RENASYS EZ MAX Negative Pressur… | 2010 |
What descends from it? (13)
See all 132 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 18 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 19 ancestors have a recall of any class.
- Of its descendants, K142979 (Smith & Nephew, Inc., 2015) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K102001.
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. 2013, 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 EZ MAX 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. Examples of appropriate wound types include: * Chronic * Acute * Traumatic * Sub-acute and dlehisced wounds * Ulcers (such as pressure or diabetic) * Partial-thickness burns * Flaps and grafts The RENASYS EZ…
Read the full statement (106 words)
RENASYS EZ MAX 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.
Examples of appropriate wound types include:
* Chronic
* Acute
* Traumatic
* Sub-acute and dlehisced wounds
* Ulcers (such as pressure or diabetic)
* Partial-thickness burns
* Flaps and grafts
The RENASYS EZ MAX Professional Healthcare Facility model (66801309) 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/K132446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132446: Renasys EZ Max Negative Pressure Wound Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132446
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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