510(k) Report

510(k) · Cleared

Cleared

Extricare

K110078510(k) TraditionalCleared Feb 10, 2012395-day reviewClass II21 CFR 878.4780

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Devon Medical Products, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on Feb 10, 2012 as substantially equivalent to K080275 (Iasis Medical, Inc., 2008) and 2 other predicates after a 395-day review. Its family tree reaches back 6 generations to 1995. 9 later devices descend from it.

Decided
Feb 10, 2012
Review
395 days
Class
Class II
Product code
OMP
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K945062 (1995). 16 ancestors in all. 9 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 2 other ancestors2007: 2 other ancestors2006: 2 other ancestors2003: 1 other ancestor1999: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor2014: 2 descendants cleared2024: 1 descendant cleared2021: 2 descendants cleared2023: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant clearedK945062 · Vacplus · Kinetic Concepts, Inc. · 1995K042134 · Versatile 1 Wound Vacuum System · Blue Sky Medical Group Incorporated · 2004 · recalledK052456 · Modification to Versatile 1 Wound Vacuum System · Blue Sky Medical Group Incorporated · 2005K061919 · Versatile 1 Ezcare Wound Vacuum System · Blue Sky Medical Group Incorporated · 2007 · recalledK082211 · Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits · Smith & Nephew, Inc. · 2008 · recalledK110647 · Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound Dressing Kits with Suction Pad; Renasys · Smith & Nephew, Inc. · 2011 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants K110647 · Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound Dressing Kits with Suction Pad; Renasys · Smith & Nephew, Inc. · 2011 · recalledK082211 · Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits · Smith & Nephew, Inc. · 2008 · recalledK061919 · Versatile 1 Ezcare Wound Vacuum System · Blue Sky Medical Group Incorporated · 2007 · recalledK052456 · Modification to Versatile 1 Wound Vacuum System · Blue Sky Medical Group Incorporated · 2005K042134 · Versatile 1 Wound Vacuum System · Blue Sky Medical Group Incorporated · 2004 · recalledK945062 · Vacplus · Kinetic Concepts, Inc. · 1995−50
  1. Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
  2. 5 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
  3. 4 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
  4. 3 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
  5. 2 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
  6. 1 generation backK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
  7. This deviceK110078 ExtricareDevon Medical Products, Inc. · 2012
  8. Descendant · cites it directly · 8 of its ownK132225 ExtricareDevon Medical, Inc. · 2014
  9. Descendant · cites it directly · 4 of its ownK140634 extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and…Devon Medical, Inc. · 2014
  10. Descendant · 2 generations on · 3 of its ownK162159 VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017
  11. Descendant · 2 generations on · 0 of its ownK241023 Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc. · 2024
  12. Descendant · 2 generations on · 0 of its ownK221223 extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices · 2023

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2014: 22017: 12019: 12021: 22022: 12023: 12024: 1
2014high 2 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · See all
  • K132225ExtricareDevon Medical, Inc. · 2014 · cites it directly8descendants
  • 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 · 2 generations on0descendants
  • K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K945062VacplusKinetic Concepts, Inc.1995—
−5K042134Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated20042
−4K052456Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated2005—
−3K061919Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated20071
−2K082211Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc.20081
−1K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT…Smith & Nephew, Inc.20116
0 (this device)K110078ExtricareDevon Medical Products, Inc.2012—
+1K132225ExtricareDevon Medical, Inc.2014—
+1K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT…Devon Medical, Inc.2014—
+2K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC2017—
+2K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.2024—
+2K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200010
200310
200620
200720
200820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201710
201910
202120
202210
202310
202410
FIG. 1 — Lineage of K110078, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260646 Renasys Edge (66803126)score 15.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K080275NPD 1000 Negative Pressure Wound Therapy System
Summary page 1
…es: The extriCARE 2400 Negative Pressure Wound Therapy System issubstantially equivalent to the following. NPID 1000 Kalypto Medical K080275 MobIVAC W.C. Ohio Medical K081185 Renasys; Gauze Smith & Nephew…
Iasis Medical, Inc.2008—
*K081185Moblvac W.C.
Summary page 1
…antially equivalent to the following. NPID 1000 Kalypto Medical K080275 MobIVAC W.C. Ohio Medical K081185 Renasys; Gauze Smith & Nephew K110647 Dressing Kit _____________…
Ohio Medical Corporation20082
*K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…
Cleared while this submission was under review
Summary page 1
…Kalypto Medical K080275 MobIVAC W.C. Ohio Medical K081185 Renasys; Gauze Smith & Nephew K110647 Dressing Kit _____________ _ _____ Device Description The system consists of a vacuum pump…
Smith & Nephew, Inc.20116

Also cleared against K080275: 3 other devices →

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132225ExtricareDevon Medical, Inc.20148
K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144

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 17 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
  • 7 of the 16 ancestors have a recall of any class.
  • Of its descendants, K132225 (Devon Medical, Inc., 2014) has gone furthest, with 8 descendants of its own.
  • 3 other devices also cite its predicate K080275.

How does its category compare?

All OMP devices

OMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OMP

5in 2025

2007: 62008: 82009: 82010: 62011: 62012: 112013: 112014: 102015: 202016: 192017: 112018: 132019: 152020: 62021: 92022: 102023: 82024: 92025: 52026 (partial year): 9
2007high 20 (2015) · low 5 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMP

127in 2025

2007: 113 days median2008: 98 days median2009: 87 days median2010: 97 days median2011: 123 days median2012: 292 days median2013: 84 days median2014: 179 days median2015: 189 days median2016: 146 days median2017: 137 days median2018: 214 days median2019: 249 days median2020: 179 days median2021: 238 days median2022: 229 days median2023: 291 days median2024: 181 days median2025: 127 days median2026 (partial year): 141 days median
2007high 292 (2012) · low 84 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OMP

2in 2024

2009: 72010: 32012: 12013: 22014: 42015: 12016: 22019: 12024: 2
2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OMP

140in 2025

2007: 12008: 12009: 792010: 802011: 1302012: 972013: 1692014: 2292015: 3782016: 3982017: 3682018: 4222019: 9942020: 3,6642021: 1,4222022: 2582023: 1432024: 1352025: 140
2007high 3,664 (2020) · low 1 (2007)2025

MAUDE reports naming product code OMP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007611301
200889801
2009887779
2010697380
201161230130
201211292197
201311842169
2014101794229
2015201891378
2016191462398
2017111370368
2018132140422
2019152491994
2020617903,664
2021923801,422
2022102290258
202382910143
202491812135
202551270140
202691410—

What is it indicated for?

The extriCARE 2400 Negative Pressure Wound Therapy Pump 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 summary.

Also cleared against K080275

3 other devices cite the same predicate.

  • K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG Antimicrobial Wound…Argentum Medical, LLC · 2014
  • K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
  • K111170PICOSmith & Nephew, Inc. · 2011

More from Devon Medical Products, Inc.

2 FDA decisions under this applicant name. See the company

  • K142168Nature's Bond 600 and Nature's Bond 603Devon Medical Products, Inc. · 2014

Recent decisions in OMP

The OMP category page

  • K261982RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)Smith & Nephew Medical, Ltd. · 2026
  • K260426MeCare Alpha (MCA2019)IVT Medical, Ltd. · 2026
  • K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026
  • K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building · 2026
  • K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd. · 2026

https://510kreport.com/device/K110078 · printed Nov 5, 2026

Cite this page

510(k) Report. “K110078: Extricare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110078

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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