510(k) · Cleared
ClearedExtricare 100CC/ 250CC/ 400CC Canisters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devon Medical · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Sep 27, 2013 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Sep 27, 2013
- Review
- 70 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK132252 Extricare 100CC/ 250CC/ 400CC CanistersDevon Medical · 2013
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K132252 | Extricare 100CC/ 250CC/ 400CC Canisters | Devon Medical | 2013 | — |
| +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 | — |
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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
- Of its descendants, K162159 (Vr Medical Technologies, LLC, 2017) has gone furthest, with 3 descendants of its own.
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. 2013, 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?
extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K132252 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132252: Extricare 100CC/ 250CC/ 400CC Canisters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132252
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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