510(k) · Cleared
ClearedNEXA Negative Pressure Wound Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexa Medical, Ltd. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jun 8, 2017 as substantially equivalent to K132741 (Kci USA, Inc., 2013) after a 262-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jun 8, 2017
- Review
- 262 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945062 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 4 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- 3 generations backK063692 V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 2007 · Recalled
- 2 generations backK093526 V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
- 1 generation backK132741 V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc. · 2013
- This deviceK162610 NEXA Negative Pressure Wound Therapy SystemNexa Medical, Ltd. · 2017
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 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −4 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| −3 | K063692 | V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000 | Kci USA, Inc. | 2007 | 1 |
| −2 | K093526 | V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C.… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010 | — |
| −1 | K132741 | V.a.C. Via Negative Pressure Wound Therapy System | Kci USA, Inc. | 2013 | — |
| 0 (this device) | K162610 | NEXA Negative Pressure Wound Therapy System | Nexa Medical, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K132741 | V.a.C. Via Negative Pressure Wound Therapy SystemSummary page 5…, Inc. (Kinetic Concepts, Inc). San Antonio, TX 78249, US Device Name V.A.C.® Via™ NPWT System FDA 510(k) No. K132741 Clearance given by FDA November 15th 2013 to market this device on FDA Device Classification Class II FDA Product Code… | 2013 |
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 22 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 3 other devices also cite its predicate K132741.
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. 2017, 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 NEXA NPWT system is intended for patients who may benefit from the application of negative pressure to the
wound to promote wound healing through the removal of excess exudate, infectious material and tissue debris.
It is intended for use in long-term care and acute settings only when prescribed by a Health Care Professional.
Appropriate wound types include:
• Chronic wounds
• Pressure ulcers
• Diabetic foot ulcers
• Venous leg ulcers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162610 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162610: NEXA Negative Pressure Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162610
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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