# K093525: Ace/Statcheck II CO2 Indicator, Ace/Statcheck II CO2 Indicator Arm Assemby Adult Statcheck Resuscitator with Ace/Statche

- Pathway: 510(k) (Special)
- Applicant: Ventlab Corp.
- Decided: Dec 10, 2009 after 24 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 1 (0 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.
0 of 1 device in its family (counting itself) have 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 

## Indications for use
The ACE/StatCheck II is intended for use as an adjunct assessment tool for verification of successful ventilation/intubation in patients >2.2 kilograms(5lbs.).

Source page: https://510kreport.com/device/K093525
Methodology: https://510kreport.com/methodology