# K072635: Clinical Electronic Thermometers, Model (S) MT901, MT518, Ect-1

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Huahui Medical Instruments Co., Ltd.
- Decided: Jan 17, 2008 after 121 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 K961879 (1996). 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)
- K062016: Rapid Digital Thermometer, Model RDT -18 Series, Choice Smart Health Care Co., Ltd. (2006) Summary page 2.

## Indications for use
The applicant device of Clinical Electronic Thermometers, Model MT901, Mode MT518 and Mode ECT-1 are the electronic thermometers by using a thermistor as the temperature sensor to measure the body temperature in oral, axillaries (underarm use), and rectal.

Source page: https://510kreport.com/device/K072635
Methodology: https://510kreport.com/methodology