# K152680: TD-1035 Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: May 6, 2016 after 231 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 K881446 (1988). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091676: MC-245, MC-246, MC-247, MC-341, MC-343, MC-344, Omron Healthcare, Inc. (2009) Summary page 4.

## Most influential descendants
- K172733: TD-1035 Thermometer (2018), 0 descendants of its own

## Indications for use
The TD-1035 Thermometer device is a thermometer intended for body temperature measurement at the axillary measurement site. The device is intended for measurement in patients 12 years and older in a home use environment.

Source page: https://510kreport.com/device/K152680
Methodology: https://510kreport.com/methodology