510(k) Report

510(k) · Cleared

Recalled · 2010

Moblvac W.C.

K081185510(k) SpecialCleared May 2, 20087-day reviewClass II21 CFR 878.4780Recalls 2

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

Ohio Medical Corporation · BTA Pump, Portable, Aspiration (Manual Or Powered)

Cleared on May 2, 2008 after a 7-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it. It has been recalled 2 times.

Decided
May 2, 2008
Review
7 days
Class
Class II
Product code
BTA
Recalls
2
Predicates
0

10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2014: 2 descendants cleared2024: 1 descendant cleared2021: 2 descendants cleared2023: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared20052010201520202025
  1. This deviceK081185 Moblvac W.C.Ohio Medical Corporation · 2008
  2. Descendant · cites it directly · 9 of its ownK110078 ExtricareDevon Medical Products, Inc. · 2012
  3. Descendant · 2 generations on · 8 of its ownK132225 ExtricareDevon Medical, Inc. · 2014
  4. Descendant · 2 generations on · 4 of its ownK140634 extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and…Devon Medical, Inc. · 2014
  5. Descendant · 3 generations on · 3 of its ownK162159 VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017
  6. Descendant · 3 generations on · 0 of its ownK241023 Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc. · 2024

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012: 12014: 22017: 12019: 12021: 22022: 12023: 12024: 1
2012high 2 (2014) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all
  • K110078ExtricareDevon Medical Products, Inc. · 2012 · cites it directly9descendants
  • K132225ExtricareDevon Medical, Inc. · 2014 · 2 generations on8descendants
  • K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc. · 2014 · 2 generations on4descendants
  • K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017 · 3 generations on3descendants
  • K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K081185Moblvac W.C.Ohio Medical Corporation2008—
+1K110078ExtricareDevon Medical Products, Inc.2012—
+2K132225ExtricareDevon Medical, Inc.2014—
+2K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT…Devon Medical, Inc.2014—
+3K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC2017—
+3K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201420
201710
201910
202120
202210
202310
202410
FIG. 1 — Lineage of K081185, 2008–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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 BTA? 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 BTA device

  1. #1 K222547 Electric nasal aspiratorscore 20.7 · 6 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110078ExtricareDevon Medical Products, Inc.20129

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 10, 2010Not classifiedZ-1778-2010OtherOhio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use.
May 10, 2010Not classifiedZ-1777-2010OtherOhio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K110078 (Devon Medical Products, Inc., 2012) has gone furthest, with 9 descendants of its own.

How does its category compare?

All BTA devices

BTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · BTA

7so far in 2026, the most since 2007

2007: 12008: 32009: 22010: 22011: 12012: 12013: 32014: 32016: 32017: 12018: 42020: 12021: 12022: 32023: 42024: 52025: 62026 (partial year): 7
2007high 7 (2026) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTA

87in 2025

2008: 135 days median2013: 45 days median2014: 91 days median2016: 149 days median2018: 125 days median2022: 58 days median2023: 265 days median2024: 131 days median2025: 87 days median2026 (partial year): 89 days median
2007high 265 (2023) · low 45 (2013)2026

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

Recalls per year · BTA

1in 2021

2007: 12008: 32010: 32021: 1
2007high 3 (2008) · low 0 (2009)2026

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

Adverse event reports per year · BTA

13in 2025

2007: 132008: 52009: 142010: 1782011: 622012: 472013: 182014: 3992015: 152016: 252017: 42018: 172019: 142020: 102021: 92022: 72023: 82024: 132025: 13
2007high 399 (2014) · low 4 (2017)2025

MAUDE reports naming product code BTA, 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
20071—113
2008313535
20092—014
20102—3178
20111—062
20121—047
2013345018
20143910399
20150—015
20163149025
20171—04
20184125017
20190—014
20201—010
20211—19
202235807
2023426508
20245131013
2025687013
20267890—

What is it indicated for?

The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the MOBLVAC W.C. is as an aspirator to be used to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient and also as a pleural and wound drainage device.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K081185: Moblvac W.C..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081185

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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