510(k) · Cleared
Recalled · 2008Bci Advisor Vital Signs Monitor (9200)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bci, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jun 12, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 35 times.
- Decided
- Jun 12, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 35
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK010770 Bci Advisor Vital Signs Monitor (9200)Bci, Inc. · 2001
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K010770 | Bci Advisor Vital Signs Monitor (9200) | Bci, Inc. | 2001 | — |
| +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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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… |
The 5 latest of 35 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030407 (Bci, Inc., 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2007high 20 (2013) · low 4 (2025)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
2007high 255 (2019) · low 42 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
2007high 9 (2026) · low 0 (2016)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
2007high 188 (2021) · low 3 (2007)2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
https://510kreport.com/device/K010770 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010770: Bci Advisor Vital Signs Monitor (9200).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010770
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026