# K902113: Vitalograph - Breathco Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mcneill Intl., Inc.
- Decided: Oct 26, 1990 after 168 days
- Product code: CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1430
- Recalls of this device: none
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K974805: CO-Stat (TM) End Tidal Breath Analyzer (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K902113
Methodology: https://510kreport.com/methodology