# K991086: Capnocheck II, Model 8400

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Jun 9, 1999 after 70 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
Longest line of descent: 1 generation back to K873856 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941982: Capnocheck, Bci, Inc. (1994) Summary page 1.
- K873856: Biochem 9090 Capnograph/SAO2, Biochem International, Inc. (1987) Summary page 1.
- K970209: Capnocheck Plus, Bci Intl., Inc. (1997) Summary page 1.

## Recalls of this device
- Jan 15, 2010 · Not classified · Z-0920-2010: Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 

## Indications for use
The 8400 Capnocheck II is a low cost CO, monitor with pulse oximeter and optional external printer. It may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient ground transport, EMS (Emergency Medical Services) and anesthesia. The capnography parameter provides end tidal CO, (ETCO,), inspired CO; (inCO,), and respiration rate measurements on all patients from pediatric to adult. The oximetry parameter works with all BCI oximetry sensors, providing %SpO, and pulse rate on all patients from pediatric to adult. The 8400 Capnocheck I permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. It is not intended nor designed to be used as an apnea monitor.

Source page: https://510kreport.com/device/K991086
Methodology: https://510kreport.com/methodology