# K982279: Vital Signs Monitor; Advisor Model # Bci 9200 - Pathway: 510(k) (Traditional) - Applicant: Bci Intl., Inc. - Decided: Sep 25, 1998 after 87 days - Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)) - Device class: 2 - Regulation: 21 CFR 870.1025 - Recalls of this device: 40 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K970801 (1997). 1 ancestor in all. 2 later devices descend from it; 1 cites it directly. 0 of 4 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K970801: Bci Model 6004 Nibp Monitor (6004), Bci Intl., Inc. (1997) Summary page 3. - (no number) BCI 6200 Vital Signs Monitor: named in the summary without a submission number - (no number) BCI 9100 Multigas Monitor: named in the summary without a submission number - (no number) Siemens SC6000 Bedside Monitor: named in the summary without a submission number ## 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 - 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 (SpO,), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). A 2-inch internal, graphical/alphanumeric 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 children (pediatric) to adults when using the appropriate BCI accessories. 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. The monitor is not intended for neonatal use. Source page: https://510kreport.com/device/K982279 Methodology: https://510kreport.com/methodology