# K030407: Advisor, Model 9200 - Pathway: 510(k) (Traditional) - Applicant: Bci, Inc. - Decided: Aug 19, 2003 after 193 days - Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) - Device class: 2 - Regulation: 21 CFR 868.1400 - Recalls of this device: 43 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K970801 (1997). 6 ancestors in all. 1 later device descends from it; 1 cites it directly. 1 of 8 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K982279: Vital Signs Monitor; Advisor Model # Bci 9200, Bci Intl., Inc. (1998) Summary page 1. - K010770: Bci Advisor Vital Signs Monitor (9200), Bci, Inc. (2001) - K011177: Bci Advisor Vital Signs Monitor (9200), Bci, Inc. (2001) - K970209: Capnocheck Plus, Bci Intl., Inc. (1997) Summary page 1. - K873856: Biochem 9090 Capnograph/SAO2, Biochem International, Inc. (1987) Summary page 1. ## Most influential descendants - 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 - Nov 29, 2017 · Class II · Z-2379-2018: Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature). - Mar 21, 2015 · Class II · Z-1692-2015: The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data co - Jan 15, 2010 · Not classified · Z-0918-2010: 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 - 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 - Jan 5, 2005 · Not classified · Z-0531-05: An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading. - Jan 5, 2005 · Not classified · Z-0532-05: An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading. - Jan 5, 2005 · Not classified · Z-0533-05: An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading. - Jan 5, 2005 · Not classified · Z-0534-05: An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading. - Jan 5, 2005 · Not classified · Z-0535-05: An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading. ## Indications for use The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead / 5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpOl), two invasive blood pressures (P1 and P2), and two temperature channels (TI and T2). Capnography (ETCO2, inCO2, RR), a two-inch internal, graphicaValphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor. Source page: https://510kreport.com/device/K030407 Methodology: https://510kreport.com/methodology