# K201032: Phoenix Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Innovative Healthcare Manufacturers Pvt., Ltd.
- Decided: Oct 29, 2021 after 557 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Phoenix Digital Thermometer is intended to measure the human body temperature orally, rectally or under the arm. The Phoenix Digital Thermometer is reusable for clinical or home use on people of all ages.

Source page: https://510kreport.com/device/K201032
Methodology: https://510kreport.com/methodology