510(k) · Cleared
ClearedUni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Ocean Medical Product, LLC · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Dec 31, 2014 as substantially equivalent to K092992 (Genadyne Biotechnologies, Inc., 2010) after a 428-day review. Its family tree reaches back 6 generations to 1995. 4 later devices descend from it.
- Decided
- Dec 31, 2014
- Review
- 428 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945062 (1995). 9 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 4 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 3 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 2 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 1 generation backK092992 A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010
- This deviceK133333 Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT…Blue Ocean Medical Product, LLC · 2014
- Descendant · cites it directly · 2 of its ownK161570 Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound…Lc Medical Concepts, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK211277 Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK232379 PREVENT KitClear Choice Therapeutics · 2024
- Descendant · cites it directly · 0 of its ownK150459 FloSure Ventilation PatchSimex Medizintechnik GmbH · 2016
Most influential descendants
Showing 4 of 4 · See all- K161570Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium…Lc Medical Concepts, Inc. · 2016 · cites it directly2descendants
- K211277Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc. · 2021 · 2 generations on1descendant
- K232379PREVENT KitClear Choice Therapeutics · 2024 · 3 generations on0descendants
- K150459FloSure Ventilation PatchSimex Medizintechnik GmbH · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −5 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −4 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −3 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −2 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −1 | K092992 | A4-XLR8 Foam Dressing | Genadyne Biotechnologies, Inc. | 2010 | — |
| 0 (this device) | K133333 | Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing… | Blue Ocean Medical Product, LLC | 2014 | — |
| +1 | K161570 | Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing… | Lc Medical Concepts, Inc. | 2016 | — |
| +2 | K211277 | Theia NPWT Foam Wound Dressing Kit | Clear Choice Therapeutics, Inc. | 2021 | — |
| +3 | K232379 | PREVENT Kit | Clear Choice Therapeutics | 2024 | — |
| +1 | K150459 | FloSure Ventilation Patch | Simex Medizintechnik GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K092992 | A4-XLR8 Foam DressingSummary page 4…alent Device Company Product 510(k) # Genadyne Biotechnologies, Inc. A4-XLR8 Foam Dressing K092992 DEVICE DESCRIPTION 807.92(a)(4) The UNI NPWT Foam Dressing Kit without… | 2010 |
| † | K113291 | Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and… | 2012 |
What descends from it? (4)
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 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K161570 (Lc Medical Concepts, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K092992.
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. 2014, 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 UNI NPWT Foam Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the UNI NPWT Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess…
Read the full statement (118 words)
The UNI NPWT Foam Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the UNI NPWT Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.
The UNI NPWT Foam Dressing Kit is appropriate for use on the following wounds:
• Pressure Ulcers
• Diabetic/Neuropathic Ulcers
• Venous Insufficiency Ulcers
• Traumatic Wounds
• Post-Operative and Dehisced Surgical Wounds
• Skin Flap and Grafts
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133333: Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133333
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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