510(k) · Cleared
ClearedVitalDetect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wellvii, Inc. · FLL Continuous Measurement Thermometer
Cleared on Feb 2, 2024 as substantially equivalent to K170047 (Shenzhen Creative Industry Co., Ltd., 2017) after a 245-day review. Its family tree reaches back 13 generations to 1994. 1 of the 120 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 2, 2024
- Review
- 245 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K941811 (1994). 119 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet. 1 of the 120 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 deviceK231625 VitalDetectWellvii, Inc. · 2024
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 deviceK231625 VitalDetectWellvii, Inc. · 2024
Class I recalls in this family
- K970209 Capnocheck Plus7 generations back · 1997
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) | K231625 | VitalDetect | Wellvii, Inc. | 2024 | — |
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 |
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 FLL device
- #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 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 |
|---|---|---|---|
| * | K170047 | All-in-One Health Monitor, PC-303Summary page 6…2910 Thermometer Classification: Class II Product Codes: DXN, Blood Pressure FLL, Thermometer, electronic, clinical Predicate Devices: Primary: All-in-One Monitor (K170047) Reference A: ARC InstaTemp MD for Temperature (K152905) Device Description: VitalDetect is a Bluetooth® connected, hand-held,… | 2017 |
| † | K152905 | ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 18 of the 119 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K170047.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, 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 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Wellvii VitalDetect™ is a device designed for spot measurements with recorded results of non-invasive blood pressure (NIBP), pulse rate (PR), and temperature (TMP).
This device uses an infra-red sensor for non-contact temperature measurement at the forehead. All other measurements use finger-based technology.
The VitalDetectTM is applicable for prescription home use by individuals 18 years of age or older for monitoring.
The device is not intended for continuous monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231625: VitalDetect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231625
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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