# K101043: Ect Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Changshan Estar Electronics Co., Ltd.
- Decided: Jul 21, 2010 after 98 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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 3.
- K041694: Digital Flexible Thermometer, Basic Digital Thermometer, Ditital Pacifier Thermometer, Hangzhou Hua'An Medical & Health Instruments Co., (2004) Summary page 1.

## Most influential descendants
- K102718: Digital Thermometer; Digital Thermometer (2010), 0 descendants of its own

## Indications for use
ECT digital thermometer is an electronic clinical thermometer which is intended to measure the human body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use on people of all ages.

Source page: https://510kreport.com/device/K101043
Methodology: https://510kreport.com/methodology