# K042013: Digital Clinical Thermometer, Models ST-8A3C and ST-8A3F

- Pathway: 510(k) (Special)
- Applicant: Mesure Technology Co., Ltd.
- Decided: Sep 8, 2004 after 43 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: 1 generation back to K981337 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981337: Digital Clinical Thermometer, Models ST-833A & ST-834A, Mesure Technology (1998) Summary page 1.

## Most influential descendants
- K070578: Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and Zset-XXX Infrared Thermometer (2007), 0 descendants of its own

## 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/K042013
Methodology: https://510kreport.com/methodology