510(k) · Cleared
ClearedVS-800 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 Dec 21, 2006 as substantially equivalent to K992638 (Critikon Company, LLC, 2000) and 2 other predicates after a 77-day review. Its family tree reaches back 7 generations to 1994. 13 later devices descend from it.
- Decided
- Dec 21, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K933143 (1994). 40 ancestors in all, the oldest K842616 (1984). 13 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 6 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 5 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 4 generations backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- 3 generations backK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
- 2 generations backK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 1 generation backK060281 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- This deviceK063055 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · cites it directly · 7 of its ownK072235 PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · Recalled
- Descendant · 2 generations on · 3 of its ownK132037 Vital Signs MonitorMindray North America · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK132038 Accutorr 7 Vital Signs MonitorMindray North America · 2014
- Descendant · cites it directly · 2 of its ownK100740 MD2000B Vital Sign Monitor, Model MD2000BBeijing Choice Electronic Technololgy Co., Ltd. · 2010
- Descendant · 3 generations on · 1 of its ownK202892 Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc. · 2021 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K072235PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · cites it directly7descendants
- K132037Vital Signs MonitorMindray North America · 2014 · 2 generations on3descendants
- K132038Accutorr 7 Vital Signs MonitorMindray North America · 2014 · 2 generations on2descendants
- K100740MD2000B Vital Sign Monitor, Model MD2000BBeijing Choice Electronic Technololgy Co., Ltd. · 2010 · cites it directly2descendants
- K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −6 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −5 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −4 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| −3 | K032733 | PM-8000 Patient Monitor, Model 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004 | — |
| −2 | K043348 | Modification to PM-8000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −1 | K060281 | VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| 0 (this device) | K063055 | VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +1 | K072235 | PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | 2 |
| +2 | K132037 | Vital Signs Monitor | Mindray North America | 2014 | 2 |
| +2 | K132038 | Accutorr 7 Vital Signs Monitor | Mindray North America | 2014 | — |
| +1 | K100740 | MD2000B Vital Sign Monitor, Model MD2000B | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
| +3 | K202892 | Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | 2021 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400Summary page 2…'<06 30-/ 510 (k) Summary Legally Marketed Predicate Devices: DINAMAP PRO MONITOR, MODEL 200 with Temperature parameter (K#992638, by CRITIKON COMPANY) SpO 2 , PR and NIBP Parameters have been previously cleared and included in: VS-800 Vi… | 2000 |
| * | K060281 | VS-800 Vital Signs MonitorSummary page 2…arameter (K#992638, by CRITIKON COMPANY) SpO 2 , PR and NIBP Parameters have been previously cleared and included in: VS-800 Vital Signs Monitor (K# 060281, by Mindray Co., Ltd.) Device Description: The VS-800 Vital Signs Monitor is a prescription device intended for use by… | 2006 |
| * | K043348 | Modification to PM-8000 Patient MonitorSummary page 4…and performs as well as or better than the legally marketed predicate device, VS-800 Vital Signs Monitor (K# 060281, Mindray), and PRO 200 Monitor (K#043348, CRITIKON COMPANY). MINDRAY'PROPRIETARY P age 4 of 4… | 2005 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 40 ancestors have a recall of any class.
- Of its descendants, K072235 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2007) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K992638.
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
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-800 Vital Signs Monitor is used to monitor physiologic parameters including SpO2, PR and NIBP, and to measure Temperature parameter on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for transport or home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063055 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063055: VS-800 Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063055
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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