# K101322: Joinsoon Electronics MFG CO., LTD Infrared Ear Thermometer, Model TT-001

- Pathway: 510(k) (Special)
- Applicant: Joinsoon Electronics Mfg Co, Ltd.
- Decided: Jul 28, 2010 after 78 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 K010235 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030299: Tempteller Infared Ear Thermometers, Model CT-31/31DX/32/32DX, Oriental System Technology, Inc. (2003) Summary page 1.

## Indications for use
The device is a clinical electronic thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

Source page: https://510kreport.com/device/K101322
Methodology: https://510kreport.com/methodology