510(k) · Cleared
ClearedUNO 30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genadyne Biotechnologies · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jan 15, 2020 as substantially equivalent to K180840 (Genadyne Biotechnologies, Inc., 2018) and 1 other predicate after a 373-day review. Its family tree reaches back 11 generations to 1995. 1 later device descends from it.
- Decided
- Jan 15, 2020
- Review
- 373 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K945062 (1995). 27 ancestors in all, the oldest K933902 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 7 generations between
- 3 generations backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- 2 generations backK161599 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2017
- 1 generation backK180840 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2018
- This deviceK190028 UNO 30Genadyne Biotechnologies · 2020
- Descendant · cites it directly · 0 of its ownK221891 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 10 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 9 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 8 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 7 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 6 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 5 generations backK111170 PICOSmith & Nephew, Inc. · 2011
- 4 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 3 generations backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- 2 generations backK161599 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2017
- 1 generation backK180840 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2018
- This deviceK190028 UNO 30Genadyne Biotechnologies · 2020
Most influential descendants
Showing 1 of 1 · See all- K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −10 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −9 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −8 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −7 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −6 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −5 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| −4 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| −3 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| −2 | K161599 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2017 | — |
| −1 | K180840 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2018 | — |
| 0 (this device) | K190028 | UNO 30 | Genadyne Biotechnologies | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K180840 | 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, K180840. The secondary predicate device is Avelle Negative Pressure Wound Therapy System K180205. Device Description The UNO 30 is port… | 2018 |
| * | K180205 | AVELLE Negative Pressure Wound Therapy SystemSummary page 4…ice The primary predicate device is UNO Negative Pressure Wound Therapy System, K180840. The secondary predicate device is Avelle Negative Pressure Wound Therapy System K180205. Device Description The UNO 30 is portable, battery powered wound suction pump with the intention to deliver negative pressure… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221891 | UNO Negative Pressure Wound Therapy System | 2022 | 0 |
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 25 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 27 ancestors have a recall of any class.
- Of its descendants, K221891 (Genadyne Biotechnologies, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K180840.
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. 2020, 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?
UNO 30 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
UNO 30 is a single patient use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190028: UNO 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190028
Report an extraction error
Are you the manufacturer?
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