510(k) · Cleared
ClearedVS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Dec 15, 2022 as substantially equivalent to K211475 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2021) after a 227-day review. Its family tree reaches back 3 generations to 2018.
- Decided
- Dec 15, 2022
- Review
- 227 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K182075 (2018). No later device cites it as a predicate yet.
- Root · 3 generations backK182075 BeneVision N Series Patient Monitors (Including BeneVision N12…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- 2 generations backK191769 ePM Series Patient monitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019
- 1 generation backK211475 Vital Signs MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2021
- This deviceK221267 VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K182075 | BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
| −2 | K191769 | ePM Series Patient monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | — |
| −1 | K211475 | Vital Signs Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021 | — |
| 0 (this device) | K221267 | VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K211475 | Vital Signs MonitorsSummary page 5…thermometer, electronic, 880.2910 thermometer clinical 3. PREDICATE DEVICE Predicate Device: K211475 - VS Series Vital Signs Monitor (SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD) 4. DEVICE DES… | 2021 |
| † | K011291 | Temporalscanner Thermometer, Sensortouch | 2001 |
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 4 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
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. 2022, 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?
The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients.
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The VS 9/VS 8/VS 8A Vital Signs Monitor are not intended for helicopter transport, hospital ambulance, or home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221267 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221267: VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221267
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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