510(k) · Cleared
Recalled · Class II · 2019Accutorr 7/VS-900/VS-900c Vital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Mar 27, 2019 as substantially equivalent to K170712 (Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., 2017) and 1 other predicate after a 174-day review. Its family tree reaches back 11 generations to 1994. It has been recalled once.
- Decided
- Mar 27, 2019
- Review
- 174 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 11 generations to K933143 (1994). 48 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet.
- Root · 11 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 7 generations between
- 3 generations backK072235 PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · Recalled
- 2 generations backK132038 Accutorr 7 Vital Signs MonitorMindray North America · 2014
- 1 generation backK170712 Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017 · Recalled
- This deviceK182821 Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019
Show all 11 generations
- Root · 11 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 10 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 9 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 8 generations backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- 7 generations backK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
- 6 generations backK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 5 generations backK060281 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 4 generations backK063055 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 3 generations backK072235 PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · Recalled
- 2 generations backK132038 Accutorr 7 Vital Signs MonitorMindray North America · 2014
- 1 generation backK170712 Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017 · Recalled
- This deviceK182821 Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −10 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −9 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −8 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| −7 | K032733 | PM-8000 Patient Monitor, Model 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004 | — |
| −6 | K043348 | Modification to PM-8000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −5 | K060281 | VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −4 | K063055 | VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −3 | K072235 | PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | 2 |
| −2 | K132038 | Accutorr 7 Vital Signs Monitor | Mindray North America | 2014 | — |
| −1 | K170712 | Accutorr 7/VS-900 Vital Signs Monitor | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017 | 1 |
| 0 (this device) | K182821 | Accutorr 7/VS-900/VS-900c Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | — |
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 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K170712 | Accutorr 7/VS-900 Vital Signs MonitorSummary page 5…Clinical electronic thermometer, electronic, 880.2910 Hospital thermometer clinical Primary Predicate Device: K170712 - Accutorr 7/VS-900 Vital Signs Monitor; SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Secondary Predicate Device: K011291 -… | 2017 |
| * | K011291 | Temporalscanner Thermometer, SensortouchSummary page 5…clinical Primary Predicate Device: K170712 - Accutorr 7/VS-900 Vital Signs Monitor; SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Secondary Predicate Device: K011291 - TEMPORALSCANNER THERMOMETER, SENSORTOUCH; EXERGEN CORP. Indications for Use: The Accutorr 7/VS-900/VS-900c Vital Signs Mon… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2019 | Class II | Z-0236-2020 | No Marketing Application | NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 48 ancestors have a recall of any class.
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. 2019, 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 Accutorr 7/VS-900/VS-900c Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
• The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182821: Accutorr 7/VS-900/VS-900c 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/K182821
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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