510(k) · Cleared
ClearedWoundPro Negative Pressure Wound Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pensar Medical, LLC · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Dec 1, 2016 as substantially equivalent to K100823 (Accuro Medical Products, LLC, 2011) and 1 other predicate after a 601-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Dec 1, 2016
- Review
- 601 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K945062 (1995). 14 ancestors in all, the oldest K933902 (1994). No later device cites it as a predicate yet.
- 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 backK061367 Bluesky Vista Wound Vacuum System, Model 100.0500Blue Sky Medical Group Incorporated · 2006
- 1 generation backK100823 Wound Pro ApexAccuro Medical Products, LLC · 2011 · Recalled
- This deviceK150960 WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC · 2016
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 | K061367 | Bluesky Vista Wound Vacuum System, Model 100.0500 | Blue Sky Medical Group Incorporated | 2006 | — |
| −1 | K100823 | Wound Pro Apex | Accuro Medical Products, LLC | 2011 | 1 |
| 0 (this device) | K150960 | WoundPro Negative Pressure Wound Therapy System | Pensar Medical, LLC | 2016 | — |
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 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K100823 | Wound Pro ApexSummary page 4…OMP (Class II, 21 CFR 878.4780) SUBSTANTIALLY EQUIVALENT TO: PREDICATE: WoundPro Apex Negative Pressure Wound Therapy Suction Pump, Accuro Medical Products, LLC –K100823 and also features of Medela INVIA Liberty K080357 DESCRIPTION of the DEVICE: The WoundPro is part of a family of products offer… | 2011 |
| * | K080357 | Medela Invia Wound TherapySummary page 4…LY EQUIVALENT TO: PREDICATE: WoundPro Apex Negative Pressure Wound Therapy Suction Pump, Accuro Medical Products, LLC –K100823 and also features of Medela INVIA Liberty K080357 DESCRIPTION of the DEVICE: The WoundPro is part of a family of products offered by Pensar Medical LLC. The WoundPro is a powere… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 4.5 years on median.
- 6 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K100823.
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?
The WoundPro Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of
infectious material and other fluids from the wound site, with continuous and/or, intermittent negative pressure. Patients with chronic,
acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts may
benefit from the use of this device. The WoundPro is intended for use in a healthcare facility only.
Additional Wounds Indicated are:
· Diabetic/Neuropathic ulcers
· Pressure ulcers
· Chronic wounds
· Acute wounds
· Dehisced wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150960 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150960: WoundPro Negative Pressure Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150960
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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