# K941982: Capnocheck

- Pathway: 510(k) (Traditional)
- Applicant: Bci, Inc.
- Decided: Oct 17, 1994 after 175 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K991086: Capnocheck II, Model 8400 (1999), 0 descendants of its own

## Recalls of this device
- Feb 14, 2025 · Class II · Z-1405-2025: Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A bre

Source page: https://510kreport.com/device/K941982
Methodology: https://510kreport.com/methodology