510(k) · Cleared
ClearedVitals360 Multi-Vitals Mobile Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vocare, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on May 20, 2021 as substantially equivalent to K170047 (Shenzhen Creative Industry Co., Ltd., 2017) and 1 other predicate after a 127-day review. Its family tree reaches back 13 generations to 1994. 1 of the 127 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- May 20, 2021
- Review
- 127 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K941811 (1994). 122 ancestors in all, the oldest K842616 (1984). 4 later devices descend from it, 3 citing it directly. 1 of the 127 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations between
- 3 generations backK053234 PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · Recalled
- 2 generations backK123711 Patient MonitorShenzhen Creative Industry Co., Ltd. · 2013
- 1 generation backK170047 All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd. · 2017
- This deviceK210086 Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK212975 MedWandMedwand Solutions, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK253436 c-med0 alphaCosinuss GmbH · 2026
- Descendant · cites it directly · 0 of its ownK231116 Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK222330 The Heart SeatCasana Care, Inc. · 2023
Show all 13 generations
- Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 12 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 11 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 10 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 9 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 8 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 7 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 6 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 5 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 4 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 3 generations backK053234 PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · Recalled
- 2 generations backK123711 Patient MonitorShenzhen Creative Industry Co., Ltd. · 2013
- 1 generation backK170047 All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd. · 2017
- This deviceK210086 Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021
Class I recalls in this family
- K970209 Capnocheck Plus7 generations back · 1997
Most influential descendants
Showing 4 of 4 · See all- K212975MedWandMedwand Solutions, Inc. · 2022 · cites it directly1descendant
- K253436c-med0 alphaCosinuss GmbH · 2026 · 2 generations on0descendants
- K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd. · 2024 · cites it directly0descendants
- K222330The Heart SeatCasana Care, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −12 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −11 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −10 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −9 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −8 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −7 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −6 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −5 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −4 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −3 | K053234 | PM-9000 Express Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | 1 |
| −2 | K123711 | Patient Monitor | Shenzhen Creative Industry Co., Ltd. | 2013 | — |
| −1 | K170047 | All-in-One Health Monitor, PC-303 | Shenzhen Creative Industry Co., Ltd. | 2017 | — |
| 0 (this device) | K210086 | Vitals360 Multi-Vitals Mobile Monitor | Vocare, Inc. | 2021 | — |
| +1 | K212975 | MedWand | Medwand Solutions, Inc. | 2022 | — |
| +2 | K253436 | c-med0 alpha | Cosinuss GmbH | 2026 | — |
| +1 | K231116 | Multi-parameter detector | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | 2024 | — |
| +1 | K222330 | The Heart Seat | Casana Care, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 6 | 0 |
| 1995 | 9 | 0 |
| 1996 | 7 | 0 |
| 1997 | 9 | 1 |
| 1998 | 11 | 0 |
| 1999 | 11 | 0 |
| 2000 | 12 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K170047 | All-in-One Health Monitor, PC-303Summary page 4…Manufacturer: Shenzhen Creative Industry Co., Ltd. Primary Predicate Trade Name: All-in-One Health Monitor, PC-303 Primary Predicate 510(k): K170047 Secondary Predicate Manufacturer: Ningbo Ranor Medical Science & Technology Co., Ltd. Secondary Predicate Trade Name:… | 2017 |
| * | K200578 | Infrared Thermometer Model Number RN-50A,RN-50BSummary page 4…Ningbo Ranor Medical Science & Technology Co., Ltd. Secondary Predicate Trade Name: Infrared Thermometer, RN-50A, RN-50B Secondary Predicate 510(k): K200578 No reference devices were used in this submission. IV. DEVICE DESCRIPTION The Vitals360® is a device designed for spot-che… | 2020 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 18 of the 122 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212975 (Medwand Solutions, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K170047.
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?
Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age.
This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.
This VITALS360® device is intended for use in a clinical or home environment.
This VITALS360® device is a reusable device following thorough cleaning between uses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210086: Vitals360 Multi-Vitals Mobile Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210086
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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