510(k) · Cleared
Recalled · 2008Vital Signs Monitor; Advisor Model # Bci 9200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bci Intl., Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Sep 25, 1998 as substantially equivalent to K970801 (Bci Intl., Inc., 1997) after an 87-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it. It has been recalled 40 times.
- Decided
- Sep 25, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 40
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970801 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970801 Bci Model 6004 Nibp Monitor (6004)Bci Intl., Inc. · 1997 · Recalled
- This deviceK982279 Vital Signs Monitor; Advisor Model # Bci 9200Bci Intl., Inc. · 1998
- Descendant · cites it directly · 1 of its ownK030407 Advisor, Model 9200Bci, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK061931 Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models…Solaris Medical Technology, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970801 | Bci Model 6004 Nibp Monitor (6004) | Bci Intl., Inc. | 1997 | 1 |
| 0 (this device) | K982279 | Vital Signs Monitor; Advisor Model # Bci 9200 | Bci Intl., Inc. | 1998 | — |
| +1 | K030407 | Advisor, Model 9200 | Bci, Inc. | 2003 | 43 |
| +2 | K061931 | Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and… | Solaris Medical Technology, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970801 | Bci Model 6004 Nibp Monitor (6004)Summary page 3…This test was to determine the accuracy of the NIBP technology using the MicroNIBP module. The next test showed that the MicroNIBP module and the BCI 6004 NIBP monitor (K970801) performed the same. This is to support the accuracy of the MAP readings. The SP-10 testing was conducted under an approved IRB… | 1997 |
| * | — | BCI 6200 Vital Signs Monitor Named without a submission number | |
| * | — | BCI 9100 Multigas Monitor Named without a submission number | |
| * | — | Siemens SC6000 Bedside Monitor Named without a submission number | |
| † | K970209 | Capnocheck Plus | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030407 | Advisor, Model 9200 | 2003 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2008 | Not classified | Z-1326-2009 | Device Design | 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 mount bracket or roll stand bracket… |
| Jun 5, 2007 | Not classified | Z-1089-2007 | Other | 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 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0228-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0237-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0239-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0221-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0224-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0226-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0229-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0232-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0234-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0236-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0238-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0240-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0222-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0220-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0223-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0225-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0230-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0231-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0233-06 | Other | 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 detect function is turned on and the… |
| Sep 1, 2005 | Not classified | Z-0235-06 | Other | 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 detect function is turned on and the… |
| Mar 16, 2005 | Not classified | Z-0825-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Mar 16, 2005 | Not classified | Z-0826-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Mar 16, 2005 | Not classified | Z-0827-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Mar 16, 2005 | Not classified | Z-0828-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Mar 16, 2005 | Not classified | Z-0831-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Mar 16, 2005 | Not classified | Z-0834-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Mar 16, 2005 | Not classified | Z-0824-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Mar 16, 2005 | Not classified | Z-0829-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Mar 16, 2005 | Not classified | Z-0830-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Mar 16, 2005 | Not classified | Z-0833-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Mar 16, 2005 | Not classified | Z-0832-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Mar 16, 2005 | Not classified | Z-0835-05 | Other | 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 elevations above 4,100 feet (at standard… |
| Jan 5, 2005 | Not classified | Z-0531-05 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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. |
The 5 latest of 40 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
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…
Read the full statement (162 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982279: Vital Signs Monitor; Advisor Model # Bci 9200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982279
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026