510(k) · Cleared
ClearedUNO Negative Pressure Wound Therapy System
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 14, 2022 as substantially equivalent to K190028 (Genadyne Biotechnologies, 2020) after a 168-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Dec 14, 2022
- Review
- 168 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K945062 (1995). 28 ancestors in all, the oldest K933902 (1994). No later device cites it as a predicate yet.
- Root · 12 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 8 generations between
- 3 generations backK161599 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2017
- 2 generations backK180840 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2018
- 1 generation backK190028 UNO 30Genadyne Biotechnologies · 2020
- This deviceK221891 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 11 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 10 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 9 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 8 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 7 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 6 generations backK111170 PICOSmith & Nephew, Inc. · 2011
- 5 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 4 generations backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- 3 generations backK161599 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2017
- 2 generations backK180840 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2018
- 1 generation backK190028 UNO 30Genadyne Biotechnologies · 2020
- This deviceK221891 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −11 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −10 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −9 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −8 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −7 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −6 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| −5 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| −4 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| −3 | K161599 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2017 | — |
| −2 | K180840 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2018 | — |
| −1 | K190028 | UNO 30 | Genadyne Biotechnologies | 2020 | — |
| 0 (this device) | K221891 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2022 | — |
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 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K190028 | UNO 30Summary page 4…rgeable lithium ion batteries of current legally device 10. d. Identification of legally Genadyne UNO 30 , K190028 marketed device which we claim substantial equivalence 11. Br… | 2020 |
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 27 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 28 ancestors have a recall of any class.
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. 2022, 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?
Genadyne UNO Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from
negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to
moderate exudates and infectious material. Appropriate wound types include:
- Chronic
- Acute
- Traumatic
- Subacute and dehisced wounds
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed Surgical Incision
Genadyne UNO Negative Pressure Wound Therapy System is a single patient use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221891: UNO Negative Pressure Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221891
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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