# K982215: Manual Resuscitator with Ace

- Pathway: 510(k) (Traditional)
- Applicant: Medical Marketing Concepts
- Decided: Sep 18, 1998 after 87 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: 8 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device 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.

## Recalls of this device
- Mar 15, 2016 · Class II · Z-1880-2016: Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being 
- 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-0172-2013: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Mar 26, 2004 · Not classified · Z-0893-04: In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
- Mar 26, 2004 · Not classified · Z-0895-04: In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
- Mar 26, 2004 · Not classified · Z-0891-04: In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
- Mar 26, 2004 · Not classified · Z-0892-04: In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
- Mar 26, 2004 · Not classified · Z-0894-04: In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.

## Indications for use
Manual ventilation and assist in verification of endotracheal tube placement

Source page: https://510kreport.com/device/K982215
Methodology: https://510kreport.com/methodology