# K101232: Joinsoon Electronics MFG CO. LTD High Speed Digital Thermometer, Model TC-001

- Pathway: 510(k) (Special)
- Applicant: Joinsoon Electronics Mfg Co, Ltd.
- Decided: Jul 21, 2010 after 79 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: 4 generations back to K852954 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042202: Tempteller - High Speed Digital Thermometers, Models DT-302, DT-312, DT-412, DT-502, Oriental System Technology, Inc. (2004) Summary page 1.

## Indications for use
This device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral, armpit and rectal in the neonatal pediatric and audit population used in the clinical and home testing.

Source page: https://510kreport.com/device/K101232
Methodology: https://510kreport.com/methodology