510(k) · Cleared
ClearedGenadyne DUO NPWT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genadyne Biotechnologies, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Dec 23, 2024 as substantially equivalent to K162790 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2017) after a 406-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Dec 23, 2024
- Review
- 406 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945062 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 4 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 3 generations backK021501 V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc. · 2002
- 2 generations backK100657 V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
- 1 generation backK162790 V.A.C.ULTA Negative Pressure Wound Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2017 · Recalled
- This deviceK233614 Genadyne DUO NPWTGenadyne Biotechnologies, Inc. · 2024
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 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −3 | K021501 | V.a.C. Instillamat (Vacuum Assisted Closure Instillamat | Kinetic Concepts, Inc. | 2002 | — |
| −2 | K100657 | V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010 | — |
| −1 | K162790 | V.A.C.ULTA Negative Pressure Wound Therapy System | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2017 | 1 |
| 0 (this device) | K233614 | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K162790 | V.A.C.ULTA Negative Pressure Wound Therapy SystemSummary page 5…Name 21 CFR 878.4780, Powered Suction Pump Product Code OMP Classification Class II Panel General and Plastic Surgery Predicate Device V.A.C.ULTA Therapy System, K162790 Device Description The Genadyne DUO NPWT is a Negative Pressure Wound Therapy unit with instillation option. The DUO NPWT featu… | 2017 |
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 29 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K162790.
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. 2024, 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 Genadyne DUO Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. • The Genadyne DUO NPWT System, in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and…
Read the full statement (141 words)
The Genadyne DUO Negative Pressure Wound Therapy System is an integrated wound management system that provides
Negative Pressure Wound Therapy with an instillation option.
• The Genadyne DUO NPWT System, in the absence of instillation is intended to create
an environment that promotes wound healing 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.
• Instillation therapy is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of
topical wound treatment solutions and suspensions over the wound bed.
The Genadyne DUO Negative Pressure Wound Therapy System with and without instillation is indicated for patients with
chronic, acute, traumatic, sub acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and
venous insufficiency), flaps and grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233614: Genadyne DUO NPWT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233614
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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