510(k) · Cleared
Recalled · Class II · 2016Renasys GO Negative Pressure Wound Therapy
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 Feb 25, 2009 as substantially equivalent to K082426 (Smith & Nephew, Inc., 2008) and 2 other predicates after a 103-day review. Its family tree reaches back 5 generations to 1995. 56 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 25, 2009
- Review
- 103 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 5 generations to K945062 (1995). 16 ancestors in all, the oldest K933902 (1994). 56 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 4 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 3 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 2 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 1 generation backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- This deviceK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 25 of its ownK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- Descendant · 2 generations on · 23 of its ownK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- Descendant · cites it directly · 15 of its ownK091470 Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 14 of its ownK102001 Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc. · 2010 · Recalled
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K111170PICOSmith & Nephew, Inc. · 2011 · cites it directly26descendants
- K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012 · cites it directly25descendants
- K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016 · 2 generations on23descendants
- K091470Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · cites it directly15descendants
- K102001Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc. · 2010 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −4 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −3 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −2 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −1 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| 0 (this device) | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | — |
| +1 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| +1 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| +2 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| +1 | K091470 | Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 | Smith & Nephew, Inc. | 2009 | 1 |
| +2 | K102001 | Modification to Renasys EZ Plus Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2010 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (3)
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…Predicate Device Information: RenaSySTm EZ Negative Pressure Wound Therapy System Smith & Nephew, Inc. 51 0(k) #K082426 Largo, FL Antlia IITM Suction Pump System Innovative Therapies, Inc. 51… | 2008 |
| * | K070904 | Antlia II Suction Pump SystemSummary page 1…51 0(k) #K082426 Largo, FL Antlia IITM Suction Pump System Innovative Therapies, Inc. 51 0(k) #K070904 Hunt Valley, MD Medela® INVIA Liberty Secretion & Surgical Aspirator 51 0(k) #K080357 Medela AG… | 2007 |
| * | K080357 | Medela Invia Wound TherapySummary page 1…vative Therapies, Inc. 51 0(k) #K070904 Hunt Valley, MD Medela® INVIA Liberty Secretion & Surgical Aspirator 51 0(k) #K080357 Medela AG Laettichstrasse, Switzerland 5. Device Description: The Renasys GO NPWT device isa… | 2008 |
What descends from it? (56)
See all 566 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111170 | PICO | 2011 | 26 |
| K112127 | Pico Single Use Negative Pressure Wound Therapy System | 2012 | 25 |
| K091470 | Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 | 2009 | 15 |
| K113678 | Invia Motion Negative Pressure Wound Therapy System | 2012 | 11 |
| K152163 | Renasys GO | 2016 | 0 |
| K111949 | AC Wound Treatment System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2016 | Class II | Z-1042-2017 | No Marketing Application | Lack of 510k clearance for design modification. |
| Nov 11, 2016 | Class II | Z-1041-2017 | No Marketing Application | Lack of 510k clearance for design modification. |
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.
- 7 of the 16 ancestors have a recall of any class.
- Of its descendants, K111170 (Smith & Nephew, Inc., 2011) has gone furthest, with 26 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?
Renasys TM GO is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing 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/K083375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083375: Renasys GO Negative Pressure Wound Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083375
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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