# K970209: Capnocheck Plus

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Apr 18, 1997 after 87 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
284 later devices descend from it; 4 cite it directly.
2 of 285 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BCI 9000 Capnograph-Oximeter: named in the summary without a submission number
- (no number) BCI 9100 Multigas Monitor: named in the summary without a submission number

## Most influential descendants
- K984033: Atlas Monitor (1999), 267 descendants of its own
- K022084: Atlas Monitor, Models 200,210,220 (2002), 264 descendants of its own
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor (2006), 250 descendants of its own
- K072295: Capnostream 20 with A2 Adaptive Averaging Software (2007), 197 descendants of its own
- K082268: CAPNOSTREAM20 with Integrated Pulmonary Index (2009), 170 descendants of its own

## Recalls of this device
- Feb 6, 2013 · Class I · Z-1014-2013: In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems.

## Indications for use
The 9004 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 transport and anesthesia environments. The oximetry option works with all BCI oximetry probes providing SpO2 and pulse rate. The patient population is defined to be pediatric to adults. The 9004 permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It is not intended or designed to be used as an apnea monitor. The 9004 will operate accurately over an ambient temperature range of 32 to 122° F (0 to 50° C).

Source page: https://510kreport.com/device/K970209
Methodology: https://510kreport.com/methodology