# K070578: Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and Zset-XXX Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Zen Strong Medical Technology Co., Ltd.
- Decided: Jul 11, 2007 after 132 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 K981337 (1998). 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)
- K042013: Digital Clinical Thermometer, Models ST-8A3C and ST-8A3F, Mesure Technology Co., Ltd. (2004) Summary page 2.
- K011254: Ear Thermometer, Models ST613C and ST613F, Mesure Technology (2001) Summary page 2.

## Indications for use
The clinical thermometer / model ZSDT-XXX digital thermometer measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal processor and digital LCD (display) unit. The device is reusable and intended for oral, rectal, or armpit temperature measurement for home use on people at all ages. The clinical thermometer / model ZSET-XXX infrared thermometer are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The device is a reusable and intended for home use, on people at all ages.

Source page: https://510kreport.com/device/K070578
Methodology: https://510kreport.com/methodology