510(k) · Cleared
ClearedVital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Choice Electronic Technology Co., Ltd. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Nov 15, 2021 as substantially equivalent to K100740 (Beijing Choice Electronic Technololgy Co., Ltd., 2010) after a 161-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Nov 15, 2021
- Review
- 161 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K933143 (1994). 42 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet.
- Root · 9 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 5 generations between
- 3 generations backK060281 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 2 generations backK063055 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 1 generation backK100740 MD2000B Vital Sign Monitor, Model MD2000BBeijing Choice Electronic Technololgy Co., Ltd. · 2010
- This deviceK211754 Vital Signs MonitorBeijing Choice Electronic Technology Co., Ltd. · 2021
Show all 9 generations
- Root · 9 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 8 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 7 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 6 generations backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- 5 generations backK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
- 4 generations backK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 3 generations backK060281 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 2 generations backK063055 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 1 generation backK100740 MD2000B Vital Sign Monitor, Model MD2000BBeijing Choice Electronic Technololgy Co., Ltd. · 2010
- This deviceK211754 Vital Signs MonitorBeijing Choice Electronic Technology Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −8 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −7 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −6 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| −5 | K032733 | PM-8000 Patient Monitor, Model 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004 | — |
| −4 | K043348 | Modification to PM-8000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −3 | K060281 | VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −2 | K063055 | VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −1 | K100740 | MD2000B Vital Sign Monitor, Model MD2000B | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
| 0 (this device) | K211754 | Vital Signs Monitor | Beijing Choice Electronic Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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 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? (1)
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 |
|---|---|---|---|
| * | K100740 | MD2000B Vital Sign Monitor, Model MD2000BSummary page 5…K211754 Premarket Notification 510(k) Submission—Section II 510(k) Summary Panel: Cardiovascular 3.3 Predicate Device 510(k) Number: K100740 Common Name: Vital Signs Monitor Device Trade/Proprietary Name: Vital Signs Monitor Model: MD2000B Classification Name: Monitor,… | 2010 |
| † | K152563 | Pulse Oximeter (MD300M/MD300K2) | 2016 |
| † | K162089 | Blood Pressure Monitor | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 6 of the 42 ancestors have a recall of any class.
- 1 other device also cites its predicate K100740.
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. 2021, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 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 | — |
What is it indicated for?
Vital Signs Monitor MD2000C is a portable device indicated for measuring physiological parameters, such as NIBP, SpO2, PR, and Pulse waveform of adult and three years old and older pediatric patients in hospitals, community hospitals and medical facilities.
Vital Signs Monitor is intended for spot-checking and/or continuous monitoring of patients.
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/K211754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211754: Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211754
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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