510(k) · Cleared
ClearedPREVENT Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clear Choice Therapeutics · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Feb 5, 2024 as substantially equivalent to K211277 (Clear Choice Therapeutics, Inc., 2021) after a 181-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Feb 5, 2024
- Review
- 181 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945062 (1995). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations between
- 3 generations backK133333 Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT…Blue Ocean Medical Product, LLC · 2014
- 2 generations backK161570 Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound…Lc Medical Concepts, Inc. · 2016
- 1 generation backK211277 Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc. · 2021
- This deviceK232379 PREVENT KitClear Choice Therapeutics · 2024
Show all 9 generations
- Root · 9 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 8 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 7 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 6 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 5 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 4 generations backK092992 A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010
- 3 generations backK133333 Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT…Blue Ocean Medical Product, LLC · 2014
- 2 generations backK161570 Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound…Lc Medical Concepts, Inc. · 2016
- 1 generation backK211277 Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc. · 2021
- This deviceK232379 PREVENT KitClear Choice Therapeutics · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −8 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −7 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −6 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −5 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −4 | K092992 | A4-XLR8 Foam Dressing | Genadyne Biotechnologies, Inc. | 2010 | — |
| −3 | K133333 | Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing… | Blue Ocean Medical Product, LLC | 2014 | — |
| −2 | K161570 | Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing… | Lc Medical Concepts, Inc. | 2016 | — |
| −1 | K211277 | Theia NPWT Foam Wound Dressing Kit | Clear Choice Therapeutics, Inc. | 2021 | — |
| 0 (this device) | K232379 | PREVENT Kit | Clear Choice Therapeutics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K211277 | Theia NPWT Foam Wound Dressing KitSummary page 6…: OMP Classification: Class II Panel: General and Plastic Surgery Predicate Device THEIA NPWT Wound Foam Dressing Kit, K211277 Device Description The PREVENT™ Kit is used with the CCT1 and CCT Mini NPWT Drainage Pumps for negative pressure wound ther… | 2021 |
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 8 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 12 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. 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 PREVENT™ Kit is intended to be used as an alternative to foam and other negative pressure wound therapy dressings when used in conjunction with the CCT1 and CCT Mini Negative Pressure Wound Drainage Pumps (K082311) for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT1 or CCT Mini Negative Pressure Wound Drainage Pumps, the PREVENT™ Kit is indicated for patients who would benefit from a suction…
Read the full statement (136 words)
The PREVENT™ Kit is intended to be used as an alternative to foam and other negative pressure wound therapy dressings when used in conjunction with the CCT1 and CCT Mini Negative Pressure Wound Drainage Pumps (K082311) for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT1 or CCT Mini Negative Pressure Wound Drainage Pumps, the PREVENT™ Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudate, infectious material and tissue debris.
The PREVENT™ 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 Flaps and Grafts
The system is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232379 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232379: PREVENT Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232379
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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