# K112116: Digital Clinical Thermometer Model V901US

- Pathway: 510(k) (Special)
- Applicant: Amperor-Electronic (Sz) Co., Ltd.
- Decided: Oct 4, 2011 after 71 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: 1 generation back to K082266 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082266: Digital Clinical Thermometer Model V9XX, Amperor-Electronic (Sz) Co., Ltd. (2008) Summary page 2.

## Indications for use
The Digital Thermometer Model V901 US is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. This thermometer is intended for the adult and pediatric population. The Digital Thermometer Model V901 US is a hand-held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive or Instant mode (10-seconds in oral, rectal mode and under the arm mode-predicative temperature), or standard mode (actual determination of temperature).

Source page: https://510kreport.com/device/K112116
Methodology: https://510kreport.com/methodology