# K152975: VDT985US Vicks SmartTemp Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Kaz USA, Inc., A Helen of Troy Company
- Decided: Mar 23, 2016 after 167 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: 8 generations back to K010462 (2001). 15 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043110: Microlife Instant Digital Electronic Thermometer, Model MT18L1, Microlife Intellectual Property GmbH (2004) Summary page 4.
- K132761: Wireless Thermometer, Raiing Medical Company (2014) Summary page 4.

## Most influential descendants
- K180131: Vicks RapidRead Digital Thermometer (2018), 2 descendants of its own
- K202791: iHealth Clinical Digital Thermometer (2021), 1 descendant of its own
- K211352: Electronic Thermometer (XHF2001, XHF2002) (2021), 0 descendants of its own

## Indications for use
The VDT985US Vicks® SmartTemp™ Thermometer is indicated for the intermittent measurement and monitoring of human body temperature orally, rectally or under the arm. It can be used on people of all ages except preterm babies or very small (for gestational age). This thermometer is intended to be used with Apple and Android mobile devices. It is intended for household use only.

Source page: https://510kreport.com/device/K152975
Methodology: https://510kreport.com/methodology