510(k) Report

510(k) · Cleared

Recalled · Class I · 2023

V*Care Manual Resuscitator

K012842510(k) SpecialCleared Sep 18, 200126-day reviewClass II21 CFR 868.5915Recalls 21 (12 Class I)

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

Ventlab Corp. · BTM Ventilator, Emergency, Manual (Resuscitator)

Cleared on Sep 18, 2001 after a 26-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 21 times, including 12 Class I recalls.

Decided
Sep 18, 2001
Review
26 days
Class
Class II
Product code
BTM
Recalls
21 (12 Class I)
Predicates
0

1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2006: 1 descendant cleared200020052010201520202025
  1. This deviceK012842 V*Care Manual ResuscitatorVentlab Corp. · 2001
  2. Descendant · cites it directly · 0 of its ownK053466 Hsiner ResuscitatorHsiner Co., Ltd. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K053466Hsiner ResuscitatorHsiner Co., Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012842V*Care Manual ResuscitatorVentlab Corp.2001—
+1K053466Hsiner ResuscitatorHsiner Co., Ltd.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K012842, 2001–2006Source: 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.

1 device in this family has a Class I recall. 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 BTM device

  1. #1 K243861 butterflyBVMscore 9.5 · 2 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K053466Hsiner ResuscitatorHsiner Co., Ltd.20060

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 11, 2023Class IIZ-0365-2024Device DesignA backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Oct 11, 2023Class IIZ-0369-2024Device DesignA backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Oct 11, 2023Class IIZ-0361-2024Device DesignA backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Oct 11, 2023Class IIZ-0366-2024Device DesignA backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Oct 11, 2023Class IIZ-0364-2024Device DesignA backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Oct 11, 2023Class IIZ-0362-2024Device DesignA backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Oct 11, 2023Class IIZ-0363-2024Device DesignA backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Oct 11, 2023Class IIZ-0367-2024Device DesignA backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Oct 11, 2023Class IIZ-0368-2024Device DesignA backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
May 16, 2014Class IZ-1948-2014Process change controlThe pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.
Jul 11, 2012Class IZ-0173-2013Component design/selectionPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Jul 11, 2012Class IZ-0175-2013Component design/selectionPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Jul 11, 2012Class IZ-0177-2013Component design/selectionPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Jul 11, 2012Class IZ-0171-2013Component design/selectionPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Jul 11, 2012Class IZ-0174-2013Component design/selectionPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Jul 11, 2012Class IZ-0176-2013Component design/selectionPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Jul 11, 2012Class IZ-0180-2013Component design/selectionPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Jul 11, 2012Class IZ-0170-2013Component design/selectionPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Jul 11, 2012Class IZ-0178-2013Component design/selectionPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Jul 11, 2012Class IZ-0179-2013Component design/selectionPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Jul 11, 2012Class IZ-0181-2013Component design/selectionPossible volume leakage through the inlet valve during compressions of the resuscitator bag.

The 5 latest of 21 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K053466 (Hsiner Co., Ltd., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BTM devices

BTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTM

2in 2025

2007: 22008: 32010: 22011: 22012: 12015: 12016: 12018: 22021: 12022: 12023: 12025: 22026 (partial year): 1
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTM

83in 2008

2008: 83 days median
2007high 83 (2008)2026

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

Recalls per year · BTM

9in 2024

2009: 232010: 32012: 13, 13 Class I2013: 3, 1 Class I2023: 92024: 9, 9 Class I2026 (partial year): 1, 1 Class I
2007high 23 (2009) · low 0 (2007)2026

Class I (24 since 2007) Class II/III not classified

Adverse event reports per year · BTM

36in 2025

2007: 652008: 312009: 212010: 232011: 482012: 692013: 442014: 1082015: 362016: 922017: 562018: 562019: 462020: 262021: 422022: 352023: 462024: 332025: 36
2007high 108 (2014) · low 21 (2009)2025

MAUDE reports naming product code BTM, 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
20072—065
2008383031
20090—2321
20102—323
20112—048
20121—13 (13)69
20130—3 (1)44
20140—0108
20151—036
20161—092
20170—056
20182—056
20190—046
20200—026
20211—042
20221—035
20231—946
20240—9 (9)33
20252—036
20261—1 (1)—

What is it indicated for?

The V*Care Manual Resuscitator with Built-in Pressure Monitor's intended use is to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Ventlab Corp.

22 FDA decisions under this applicant name. See the company

  • K120118Ventlab Pressurechek Disosable Column ManometerVentlab Corp. · 2012
  • K102674Cuff SentryVentlab Corp. · 2011
  • K093617Ventlab 6000 Series HumidifierVentlab Corp. · 2011
  • K093525Ace/Statcheck II CO2 Indicator, Ace/Statcheck II CO2 Indicator Arm Assemby Adult Statcheck Resuscitator with…Ventlab Corp. · 20091 recall
  • K090840Ventlab 5000 Series Nebulizer Assembly, Cup, Cup W/ Mask, Cup W/ Fitsall Conn.Ventlab Corp. · 2009

Recent decisions in BTM

The BTM category page

  • K263254Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)Xiamen Compower Medical Tech. Co., Ltd. · 2026
  • K251631The BAG manual resuscitator and accessoriesLaerdal Medical AS · 2025
  • K243861butterflyBVMCompact Medical, Inc. · 2025
  • K221841EOlife®Archeon · 2023
  • K212905Sotair DeviceSafe Bvm Corporation · 2022

https://510kreport.com/device/K012842 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012842: V*Care Manual Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012842

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026