# K132140: Duteck (Michealth)Digital Clinical Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Duteck Industrial Co., Ltd.
- Decided: Feb 4, 2014 after 208 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 K992327 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992327: Duteck Digital Clinical Thermometer, Duteck Industrial Co., Ltd. (1999) Summary page 2.

## Indications for use
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series (product code I'LL) is used to measure human body temperature with the following features: The device display body temperature in digital format at LCID The device make intended contact with patient in 2 ways (1) Surface contact: armpit. (2) Invasive contact: oral. The device is used and installed by patients, Nurses, doctors and people with the exception of handicapped people and children. The device is used in ENVIRONMIENT of room temperature and normal environment condition.

Source page: https://510kreport.com/device/K132140
Methodology: https://510kreport.com/methodology