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 Nov 30, 2018 as substantially equivalent to K161599 (Genadyne Biotechnologies, Inc., 2017) and 1 other predicate after a 245-day review. Its family tree reaches back 10 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 30, 2018
- Review
- 245 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K945062 (1995). 25 ancestors in all, the oldest K933902 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 6 generations between
- 3 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 2 generations backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- 1 generation backK161599 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2017
- This deviceK180840 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK190028 UNO 30Genadyne Biotechnologies · 2020
- Descendant · 2 generations on · 0 of its ownK221891 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK181929 MiMo (TM) Negative Pressure Wound Therapy SystemBaymax Research, Inc. · 2019
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 backK111170 PICOSmith & Nephew, Inc. · 2011
- 3 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 2 generations backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- 1 generation backK161599 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2017
- This deviceK180840 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K190028UNO 30Genadyne Biotechnologies · 2020 · cites it directly1descendant
- K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2022 · 2 generations on0descendants
- K181929MiMo (TM) Negative Pressure Wound Therapy SystemBaymax Research, Inc. · 2019 · cites it directly0descendants
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 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| −3 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| −2 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| −1 | K161599 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2017 | — |
| 0 (this device) | K180840 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2018 | — |
| +1 | K190028 | UNO 30 | Genadyne Biotechnologies | 2020 | — |
| +2 | K221891 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2022 | — |
| +1 | K181929 | MiMo (TM) Negative Pressure Wound Therapy System | Baymax Research, Inc. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K161599 | UNO Negative Pressure Wound Therapy SystemSummary page 4…Negative Pressure Wound Therapy Powered Suction Pump 21 C.F.R. § 878.4780 Predicate Device The primary predicate device is UNO Negative Pressure Wound Therapy System, K161599. The proposed device and the primary predicate device are similar in terms of their technological characteristics. The secondary… | 2017 |
| * | K151436 | PICO Single Use Negative Pressure Wound Therapy SystemSummary page 4…y predicate device are similar in terms of their technological characteristics. The secondary predicate device is Pico Single Use Negative Pressure Wound Therapy System, K151436.The proposed device and the secondary predicate device are similar in terms of their indications for use. Device Description Th… | 2016 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 25 ancestors have a recall of any class.
- Of its descendants, K190028 (Genadyne Biotechnologies, 2020) has gone furthest, with 1 descendant of its own.
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. 2018, 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 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
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed surgical incision
Genadyne UNO is a single patient use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180840: 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/K180840
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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