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. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 23, 2006 as substantially equivalent to K043348 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2005) after a 140-day review. Its family tree reaches back 6 generations to 1994. 16 later devices descend from it.
- Decided
- Jun 23, 2006
- Review
- 140 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K933143 (1994). 26 ancestors in all, the oldest K842616 (1984). 16 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 5 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 4 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 3 generations backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- 2 generations backK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
- 1 generation backK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- This deviceK060281 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · cites it directly · 13 of its ownK063055 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · 2 generations on · 7 of its ownK072235 PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · Recalled
- Descendant · 3 generations on · 3 of its ownK132037 Vital Signs MonitorMindray North America · 2014 · Recalled
- Descendant · 3 generations on · 2 of its ownK132038 Accutorr 7 Vital Signs MonitorMindray North America · 2014
- Descendant · 2 generations on · 2 of its ownK100740 MD2000B Vital Sign Monitor, Model MD2000BBeijing Choice Electronic Technololgy Co., Ltd. · 2010
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K063055VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · cites it directly13descendants
- K072235PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 2 generations on7descendants
- K132037Vital Signs MonitorMindray North America · 2014 · 3 generations on3descendants
- K132038Accutorr 7 Vital Signs MonitorMindray North America · 2014 · 3 generations on2descendants
- K100740MD2000B Vital Sign Monitor, Model MD2000BBeijing Choice Electronic Technololgy Co., Ltd. · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −5 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −4 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −3 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| −2 | K032733 | PM-8000 Patient Monitor, Model 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004 | — |
| −1 | K043348 | Modification to PM-8000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| 0 (this device) | K060281 | VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +1 | K063055 | VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +2 | K072235 | PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | 2 |
| +3 | K132037 | Vital Signs Monitor | Mindray North America | 2014 | 2 |
| +3 | K132038 | Accutorr 7 Vital Signs Monitor | Mindray North America | 2014 | — |
| +2 | K100740 | MD2000B Vital Sign Monitor, Model MD2000B | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K043348 | Modification to PM-8000 Patient MonitorSummary page 1…Class H 21 CFR 870.271 0 Ear Oximeter, Pulse Class El Legally Marketed Predicate Device: K043348 PM-8000 Patient Monitor (by Mindray Co., Ltd.) Page I of 4… | 2005 |
What descends from it? (16)
See all 162 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 1.6 years on median.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K063055 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2006) has gone furthest, with 13 descendants of its own.
- 4 other devices also cite its predicate K043348.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The VS-800 Vital Signs Monitor is used to monitor physiological
parameters, including SpO2 , PR and NIBP on adults, pediatric and
neonatal patients in healthcare facilities by clinical physicians or
appropriate medical staff under the direction of physicians.
The device is not intended for transport or home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060281: VS-800 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/K060281
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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