510(k) · Cleared
ClearedWound Geni NPWT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bechtel Medical, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on May 4, 2026 as substantially equivalent to K172145 (Medela AG, 2018) after a 140-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- May 4, 2026
- Review
- 140 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K945062 (1995). 38 ancestors in all, the oldest K914604 (1992). No later device cites it as a predicate yet.
- Root · 10 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 6 generations between
- 3 generations backK141926 Invia Endure Negative Pressure Wound Therapy SystemMedela AG · 2014
- 2 generations backK161128 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia…Medela AG · 2016 · Recalled
- 1 generation backK172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure…Medela AG · 2018
- This deviceK254019 Wound Geni NPWT SystemBechtel Medical, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 9 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 8 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 7 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 6 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 5 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 4 generations backK113678 Invia Motion Negative Pressure Wound Therapy SystemMedela AG · 2012
- 3 generations backK141926 Invia Endure Negative Pressure Wound Therapy SystemMedela AG · 2014
- 2 generations backK161128 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia…Medela AG · 2016 · Recalled
- 1 generation backK172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure…Medela AG · 2018
- This deviceK254019 Wound Geni NPWT SystemBechtel Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −9 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −8 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −7 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −6 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −5 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −4 | K113678 | Invia Motion Negative Pressure Wound Therapy System | Medela AG | 2012 | — |
| −3 | K141926 | Invia Endure Negative Pressure Wound Therapy System | Medela AG | 2014 | — |
| −2 | K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120… | Medela AG | 2016 | 1 |
| −1 | K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound… | Medela AG | 2018 | — |
| 0 (this device) | K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Summary page 5…ry Class: Class II Medela AG: Invia Liberty Negative Pressure Wound Therapy Predicate Device: System (K172145) (Pump and canister only) Page 1 of 6… | 2018 |
| † | K150960 | WoundPro Negative Pressure Wound Therapy System | 2016 |
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 31 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 14 of the 38 ancestors have a recall of any class.
- 2 other devices also cite its predicate K172145.
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. 2026, 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 Wound Geni™ NPWT System is indicated for patients who would benefit from a suction device (NPWT). It creates an environment that allows wound management by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. When used on closed surgical incisions, the Wound Geni™ NPWT System is also intended to…
Read the full statement (165 words)
The Wound Geni™ NPWT System is indicated for patients who would benefit from a suction device (NPWT). It creates an environment that allows wound management by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
When used on closed surgical incisions, the Wound Geni™ NPWT System is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.
The Wound Geni™ NPWT System can only be used with Pensar WoundPro Foam Dressing Kits (K150960).
The Wound Geni™ NPWT System is appropriate for use for the following indications:
• Acute or subacute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic, Neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial-thickness burns
• Flaps and grafts
• Closed surgical incisions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254019 · printed Nov 5, 2026
Cite this page
510(k) Report. “K254019: Wound Geni NPWT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K254019
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026