510(k) · Cleared
Recalled · 2010Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059
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 Jul 9, 2009 as substantially equivalent to K082426 (Smith & Nephew, Inc., 2008) and 1 other predicate after a 52-day review. Its family tree reaches back 6 generations to 1995. 15 later devices descend from it. It has been recalled once.
- Decided
- Jul 9, 2009
- Review
- 52 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945062 (1995). 17 ancestors in all, the oldest K933902 (1994). 15 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 4 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 3 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 2 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 1 generation backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- This deviceK091470 Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009
- Descendant · cites it directly · 14 of its ownK102001 Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 13 of its ownK132446 Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc. · 2013
- Descendant · 2 generations on · 12 of its ownK142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound…Smith & Nephew, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 5 of its ownK153209 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH…Smith & Nephew Medical, Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB…Smith & Nephew, Inc. · 2015
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K102001Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc. · 2010 · cites it directly14descendants
- K132446Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc. · 2013 · 2 generations on13descendants
- K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc. · 2015 · 2 generations on12descendants
- K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd. · 2016 · 3 generations on5descendants
- K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc. · 2015 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −5 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −4 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −3 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −2 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −1 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| 0 (this device) | K091470 | Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 | Smith & Nephew, Inc. | 2009 | — |
| +1 | 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 | — |
| +2 | K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits… | Smith & Nephew, Inc. | 2015 | 1 |
| +3 | K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters… | Smith & Nephew Medical, Ltd. | 2016 | — |
| +2 | K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal… | Smith & Nephew, Inc. | 2015 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K082426 | Renasys EZSummary page 1…ss II, OMP 4. Predicate Device Information: RENASYS Tm EZ Negative Pressure Wound Therapy System Smith & Nephew, Inc. 51 0(k) #k082426 Largo, FL RENASYS Tm GO Negative Pressure Wound Therapy System Smith & Nephew, Inc. 5… | 2008 |
| * | K083375 | Renasys GO Negative Pressure Wound TherapySummary page 1…51 0(k) #k082426 Largo, FL RENASYS Tm GO Negative Pressure Wound Therapy System Smith & Nephew, Inc. 51 0(k) # k083375 Largo, FL 5. Device Description: The RENASYS m EZ NPWT device is a lightweight, portable suction… | 2009 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102001 | Modification to Renasys EZ Plus Negative Pressure Wound Therapy | 2010 | 14 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2010 | Not classified | Z-0310-2011 | Other | Smith&Nephew Inc., Advance Wound Management, St Petersburg, FL is recalling their Ezcare Negative Pressure Wound Therapy pumps manufactured by BlueSky Medical Group Inc., between July 17, 2007 and December 13, 2007 and distributed by… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 17 ancestors have a recall of any class.
- Of its descendants, K102001 (Smith & Nephew, Inc., 2010) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K082426.
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. 2009, 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 EZ is indicated for patients who would benefit from a suction device
(negative pressure) as it may promote wound healing via the 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 dehisced wounds, Ulcers (such as pressure or diabetic), Partial-thickness burns, Flaps and Grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091470 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091470: Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091470
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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