510(k) · Cleared
ClearedExtricare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devon Medical, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on May 15, 2014 as substantially equivalent to K110078 (Devon Medical Products, Inc., 2012) and 3 other predicates after a 302-day review. Its family tree reaches back 7 generations to 1995. 8 later devices descend from it.
- Decided
- May 15, 2014
- Review
- 302 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K945062 (1995). 24 ancestors in all, the oldest K933902 (1994). 8 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 6 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 5 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 4 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 3 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 2 generations backK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
- 1 generation backK110078 ExtricareDevon Medical Products, Inc. · 2012
- This deviceK132225 ExtricareDevon Medical, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK140634 extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and…Devon Medical, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK162159 VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017
- Descendant · cites it directly · 0 of its ownK241023 Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK221223 extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices · 2023
- Descendant · 3 generations on · 0 of its ownK211571 Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc. · 2014 · cites it directly4descendants
- K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017 · 2 generations on3descendants
- K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc. · 2024 · cites it directly0descendants
- K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices · 2023 · cites it directly0descendants
- K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −6 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −5 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −4 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −3 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −2 | K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT… | Smith & Nephew, Inc. | 2011 | 6 |
| −1 | K110078 | Extricare | Devon Medical Products, Inc. | 2012 | — |
| 0 (this device) | K132225 | Extricare | Devon Medical, Inc. | 2014 | — |
| +1 | K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT… | Devon Medical, Inc. | 2014 | — |
| +2 | K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing | Vr Medical Technologies, LLC | 2017 | — |
| +1 | K241023 | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way, Inc. | 2024 | — |
| +1 | K221223 | extriCARE® 3000 Negative Wound Pressure Therapy System | Alleva Medical Devices | 2023 | — |
| +3 | K211571 | Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit | Zhejiang Longterm Medical Technology Co., Ltd. | 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 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K110078 | ExtricareSummary page 1…ally equivalent to the following: Predicate Device Manufacturer 510(k)# extriCARE 2400 Devon Medical K1 10078 V.AC® Freedom TmKinetic Concepts, Inc. K032310 Wound Pro Apex Accuro Medical Products… | 2012 |
| * | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. AtsSummary page 1…turer 510(k)# extriCARE 2400 Devon Medical K1 10078 V.AC® Freedom TmKinetic Concepts, Inc. K032310 Wound Pro Apex Accuro Medical Products K100823 __________ ____ LLC NPWT Foam… | 2003 |
| * | K100823 | Wound Pro ApexSummary page 1…cal K1 10078 V.AC® Freedom TmKinetic Concepts, Inc. K032310 Wound Pro Apex Accuro Medical Products K100823 __________ ____ LLC NPWT Foam Smith & Nephew K08221 1 Dressing Kits… | 2011 |
| * | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSummary page 1…310 Wound Pro Apex Accuro Medical Products K100823 __________ ____ LLC NPWT Foam Smith & Nephew K08221 1 Dressing Kits _____________ _ ______ Device Description The system consists of a vacuum pum… | 2008 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam… | 2014 | 4 |
| K241023 | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | 2024 | 0 |
| K221223 | extriCARE® 3000 Negative Wound Pressure Therapy System | 2023 | 0 |
| K202898 | Tzoar 207 Negative Pressure Wound Therapy (NPWT) System | 2021 | 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 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 11 of the 24 ancestors have a recall of any class.
- Of its descendants, K140634 (Devon Medical, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K110078.
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 extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132225: Extricare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132225
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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