510(k) · Cleared
Recalled · Class II · 2017Advisor, Model 9200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bci, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Aug 19, 2003 as substantially equivalent to K982279 (Bci Intl., Inc., 1998) and 4 other predicates after a 193-day review. Its family tree reaches back 2 generations to 1997. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 43 times.
- Decided
- Aug 19, 2003
- Review
- 193 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 43
- Predicates
- 5
Its longest line of descent runs back 2 generations to K970801 (1997). 6 ancestors in all, the oldest K873856 (1987). 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK970801 Bci Model 6004 Nibp Monitor (6004)Bci Intl., Inc. · 1997 · Recalled
- 1 generation backK982279 Vital Signs Monitor; Advisor Model # Bci 9200Bci Intl., Inc. · 1998 · Recalled
- This deviceK030407 Advisor, Model 9200Bci, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK061931 Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models…Solaris Medical Technology, Inc. · 2007
Class I recalls in this family
- K970209 Capnocheck Plusdirect predicate · 1997
Most influential descendants
Showing 1 of 1 · See all- K061931Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103…Solaris Medical Technology, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970801 | Bci Model 6004 Nibp Monitor (6004) | Bci Intl., Inc. | 1997 | 1 |
| −1 | K982279 | Vital Signs Monitor; Advisor Model # Bci 9200 | Bci Intl., Inc. | 1998 | 40 |
| 0 (this device) | K030407 | Advisor, Model 9200 | Bci, Inc. | 2003 | — |
| +1 | K061931 | Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and… | Solaris Medical Technology, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1997 | 1 | 1 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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 CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K982279 | Vital Signs Monitor; Advisor Model # Bci 9200Summary page 1…new capnography option. CommodClassification Name: Vital signs monitor Predicate Devices: BCITM9200 vital signs monitor (K982279, KO10770, KO 11177) BCITM9004 moni… | 1998 |
| * | K010770 | Bci Advisor Vital Signs Monitor (9200) | 2001 |
| * | K011177 | Bci Advisor Vital Signs Monitor (9200) | 2001 |
| * | K970209 | Capnocheck PlusSummary page 1…TM9200 vital signs monitor (K982279, KO10770, KO 11177) BCITM9004 monitor (K970209) BCITM9000 monitor (K873856) New Device Description: The BCI 9200 vital signs… | 1997 |
| * | K873856 | Biochem 9090 Capnograph/SAO2Summary page 1…KO10770, KO 11177) BCITM9004 monitor (K970209) BCITM9000 monitor (K873856) New Device Description: The BCI 9200 vital signs monitor has been updated to include a new capnography option. This new feat… | 1987 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061931 | Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103… | 2007 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2017 | Class II | Z-2379-2018 | Software design | 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 | Nonconforming Material/Component | 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 collection system. |
| Jan 15, 2010 | Not classified | Z-0918-2010 | Nonconforming Material/Component | 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 Advisor Vital Signs Monitor(Human or… |
| 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 43 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 5 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K061931 (Solaris Medical Technology, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
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 (SpOl), two invasive blood pressures (P1 and P2), and two temperature channels (TI and T2). Capnography…
Read the full statement (200 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 (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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030407 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030407: Advisor, Model 9200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030407
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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