# K010770: Bci Advisor Vital Signs Monitor (9200)

- Pathway: 510(k) (Traditional)
- Applicant: Bci, Inc.
- Decided: Jun 12, 2001 after 90 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 35 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K030407: Advisor, Model 9200 (2003), 1 descendant of its own
- K061931: Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103, S200A-090101 and 300101 (2007), 0 descendants of its own

## Recalls of this device
- Dec 22, 2008 · Not classified · Z-1326-2009: Recent improvements were made to the Advisor case plastic resulting in the inserts being deeply embedded into the plastic. This affects the ability of the monitor to be adequately secured on the wall 
- Jun 5, 2007 · Not classified · Z-1089-2007: Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on.
- Sep 1, 2005 · Not classified · Z-0227-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0228-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0237-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0239-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0221-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0224-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0226-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0229-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0232-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0234-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0236-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0238-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0240-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0222-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0220-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0223-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0225-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0230-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0231-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0233-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Sep 1, 2005 · Not classified · Z-0235-06: Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace det
- Mar 16, 2005 · Not classified · Z-0825-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el
- Mar 16, 2005 · Not classified · Z-0826-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el
- Mar 16, 2005 · Not classified · Z-0827-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el
- Mar 16, 2005 · Not classified · Z-0828-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el
- Mar 16, 2005 · Not classified · Z-0831-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el
- Mar 16, 2005 · Not classified · Z-0834-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el
- Mar 16, 2005 · Not classified · Z-0824-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el
- Mar 16, 2005 · Not classified · Z-0829-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el
- Mar 16, 2005 · Not classified · Z-0830-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el
- Mar 16, 2005 · Not classified · Z-0833-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el
- Mar 16, 2005 · Not classified · Z-0832-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el
- Mar 16, 2005 · Not classified · Z-0835-05: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at el

Source page: https://510kreport.com/device/K010770
Methodology: https://510kreport.com/methodology