# K120671: Digital Pacifier Thermometer (Model NO.: TM-03)

- Pathway: 510(k) (Traditional)
- Applicant: Cotronic Technology Limited
- Decided: May 17, 2013 after 438 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: 3 generations back to K952073 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051100: Modification to:  Microlife Digital Pacifier Thermometer, Model MT1751Q, Microlife Intellectual Property GmbH (2005) Summary page 1.

## Indications for use
Digital Pacifier Thermometer TM-03 is a non-sterile, reusable & battery-operated clinical electronic thermometer for use by medical professional or at home. The TM-03 is intended to measure the oral thermometer of infant to children up to 5 years old.

Source page: https://510kreport.com/device/K120671
Methodology: https://510kreport.com/methodology