# K050303: 5 Sec Digital Clinical Thermometer, Models ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.

- Pathway: 510(k) (Special)
- Applicant: Mesure Technology Co., Ltd.
- Decided: Feb 25, 2005 after 17 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 K021048 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021048: Thermometer Models ST8631, Z7 International (2002) Summary page 1.
- K041056: 10-Second Digital Thermometer, Models ST87, ST89, ST80, ST88, Mesure Technology Co., Ltd. (2004). Our reading of the summary gave K040156, FDA’s number for Ifl Professional System, Model C100 (Cyden Limited). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “100-second Digital Thermometer, model ST87, ST89, ST80, and ST8B3”.

## Indications for use
The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

Source page: https://510kreport.com/device/K050303
Methodology: https://510kreport.com/methodology