# K231625: VitalDetect

- Pathway: 510(k) (Traditional)
- Applicant: Wellvii, Inc.
- Decided: Feb 2, 2024 after 245 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K941811 (1994). 119 ancestors in all.
No later device cites it as a predicate yet.
1 of 120 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170047: All-in-One Health Monitor, PC-303, Shenzhen Creative Industry Co., Ltd. (2017) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K231625
Methodology: https://510kreport.com/methodology