# K012842: V*Care Manual Resuscitator

- Pathway: 510(k) (Special)
- Applicant: Ventlab Corp.
- Decided: Sep 18, 2001 after 26 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: 21 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053466: Hsiner Resuscitator (2006), 0 descendants of its own

## Recalls of this device
- Oct 11, 2023 · Class II · Z-0365-2024: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- Oct 11, 2023 · Class II · Z-0369-2024: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- Oct 11, 2023 · Class II · Z-0361-2024: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- Oct 11, 2023 · Class II · Z-0366-2024: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- Oct 11, 2023 · Class II · Z-0364-2024: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- Oct 11, 2023 · Class II · Z-0362-2024: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- Oct 11, 2023 · Class II · Z-0363-2024: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- Oct 11, 2023 · Class II · Z-0367-2024: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- Oct 11, 2023 · Class II · Z-0368-2024: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
- May 16, 2014 · Class I · Z-1948-2014: The 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, 2012 · Class I · Z-0173-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Jul 11, 2012 · Class I · Z-0175-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Jul 11, 2012 · Class I · Z-0177-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Jul 11, 2012 · Class I · Z-0171-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Jul 11, 2012 · Class I · Z-0174-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Jul 11, 2012 · Class I · Z-0176-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Jul 11, 2012 · Class I · Z-0180-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Jul 11, 2012 · Class I · Z-0170-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Jul 11, 2012 · Class I · Z-0178-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Jul 11, 2012 · Class I · Z-0179-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Jul 11, 2012 · Class I · Z-0181-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

## Indications for use
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.

Source page: https://510kreport.com/device/K012842
Methodology: https://510kreport.com/methodology