510(k) · Cleared
ClearedextriCARE® 1000 Negative Pressure Wound Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alleva Medical Devices · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Oct 3, 2025 as substantially equivalent to K213906 (Alleva Medical, Ltd., 2023) after a 127-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Oct 3, 2025
- Review
- 127 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K945062 (1995). 29 ancestors in all, the oldest K933902 (1994). No later device cites it as a predicate yet.
- Root · 14 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 10 generations between
- 3 generations backK180698 PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018
- 2 generations backK191760 PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2019
- 1 generation backK213906 extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd. · 2023
- This deviceK251646 extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices · 2025
Show all 14 generations
- Root · 14 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 13 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 12 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 11 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 10 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 9 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 8 generations backK111170 PICOSmith & Nephew, Inc. · 2011
- 7 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 6 generations backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- 5 generations backK163387 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017
- 4 generations backK172005 PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018
- 3 generations backK180698 PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018
- 2 generations backK191760 PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2019
- 1 generation backK213906 extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd. · 2023
- This deviceK251646 extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −13 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −12 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −11 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −10 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −9 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −8 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| −7 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| −6 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| −5 | K163387 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2017 | — |
| −4 | K172005 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018 | — |
| −3 | K180698 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018 | — |
| −2 | K191760 | PICO 14 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2019 | — |
| −1 | K213906 | extriCARE 1000 Negative Pressure Wound Therapy System | Alleva Medical, Ltd. | 2023 | — |
| 0 (this device) | K251646 | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K213906 | extriCARE 1000 Negative Pressure Wound Therapy SystemSummary page 5…Wound Therapy Pump PRODUCT CODE OMP PREDICATE DEVICE: extriCARE® 1000 Negative Pressure Wound Therapy System (K213906) Indications for Use The extriCARE® 1000 NPWT System is intended to generate negative pressure to remove wound exudates, infecti… | 2023 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 29 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. 2025, 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 extriCARE® 1000 NPWT System is intended to generate negative pressure to remove wound exudates, infectious material, and tissue debris from the wound bed.
The extriCARE® 1000 NPWT System is intended for use in wounds with low to moderate levels of exudate. Appropriate wound types include:
• Chronic wounds
• Acute wounds
• Traumatic wounds
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcer wounds (such as diabetic or pressure)
• Flaps and grafts
• Closed surgical incisions
The extriCARE® 1000 NPWT System is intended for use in healthcare facilities. The extriCARE® 1000 NPWT System is intended for use with extriCARE® 1000 Bandage Dressings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251646 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251646: extriCARE® 1000 Negative Pressure Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251646
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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