# K032434: Clinical Electronic Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Cotronic Manufacturing
- Decided: Dec 27, 2004 after 509 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: 2 generations back to K903590 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023711: Digital Thermometer Classic Type and Flexible Type, Acute Ideas Co., Ltd. (2002) Summary page 1.

## Indications for use
The device measures the human body temperature from oral, armpit, and rectal. The device is reuseable and intended for clinical or home use on people of all ages.

Source page: https://510kreport.com/device/K032434
Methodology: https://510kreport.com/methodology