510(k) · Cleared
ClearedextriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit
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 Sep 19, 2014 as substantially equivalent to K110078 (Devon Medical Products, Inc., 2012) and 3 other predicates after a 191-day review. Its family tree reaches back 8 generations to 1995. 4 later devices descend from it.
- Decided
- Sep 19, 2014
- Review
- 191 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K945062 (1995). 26 ancestors in all, the oldest K933902 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 7 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 6 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 5 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 4 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 3 generations backK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
- 2 generations backK110078 ExtricareDevon Medical Products, Inc. · 2012
- 1 generation backK132225 ExtricareDevon Medical, Inc. · 2014
- This deviceK140634 extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and…Devon Medical, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK162159 VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017
- Descendant · 2 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
- Descendant · 2 generations on · 0 of its ownK202823 Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK182458 Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017 · cites it directly3descendants
- K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd. · 2022 · 2 generations on0descendants
- K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd. · 2021 · 2 generations on0descendants
- K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −7 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −6 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −5 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −4 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −3 | K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT… | Smith & Nephew, Inc. | 2011 | 6 |
| −2 | K110078 | Extricare | Devon Medical Products, Inc. | 2012 | — |
| −1 | K132225 | Extricare | Devon Medical, Inc. | 2014 | — |
| 0 (this device) | K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT… | Devon Medical, Inc. | 2014 | — |
| +1 | K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing | Vr Medical Technologies, LLC | 2017 | — |
| +2 | K211571 | Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit | Zhejiang Longterm Medical Technology Co., Ltd. | 2022 | — |
| +2 | K202823 | Innomed NPWT Silicone Foam Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | 2021 | — |
| +2 | K182458 | Longterm NPWT Foam Dressing Kit | Zhejiang Longterm Medical Technology Co., Ltd. | 2019 | — |
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 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 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? (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 4…: Predicate Device Manufacturer 510(k) Number extriCARE 2400 Devon Medical Products K110078 extriCARE 3600 Devon Medical Products K132225 Renasys NPWT Foam Dressing Sm… | 2012 |
| * | K132225 | Extricare Cleared while this submission was under review Summary page 4…Number extriCARE 2400 Devon Medical Products K110078 extriCARE 3600 Devon Medical Products K132225 Renasys NPWT Foam Dressing Smith & Nephew K082211 A4-XLR8 Foam Dressing Ge… | 2014 |
| * | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSummary page 4…K110078 extriCARE 3600 Devon Medical Products K132225 Renasys NPWT Foam Dressing Smith & Nephew K082211 A4-XLR8 Foam Dressing Genadyne Biotechnologies, Inc. K092992 Device Description Premarket notification… | 2008 |
| * | K092992 | A4-XLR8 Foam DressingSummary page 4…K132225 Renasys NPWT Foam Dressing Smith & Nephew K082211 A4-XLR8 Foam Dressing Genadyne Biotechnologies, Inc. K092992 Device Description Premarket notification device: ® extriCARE NPWT Foam Dressing Kit… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing | 2017 | 3 |
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 26 ancestors have a recall of any class.
- Of its descendants, K162159 (Vr Medical Technologies, LLC, 2017) has gone furthest, with 3 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® NPWT foam kit is intended to be used in conjunction with the extriCARE® 2400 NPWT pump. The extriCARE® 2400 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 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/K140634 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140634: extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140634
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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