# K030299: Tempteller Infared Ear Thermometers, Model CT-31/31DX/32/32DX

- Pathway: 510(k) (Special)
- Applicant: Oriental System Technology, Inc.
- Decided: Feb 25, 2003 after 27 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 K010235 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010235: Tempteller Infrared Ear Thermometer, Model CT-30/ CT-30DX, Oriental System Technology, Inc. (2001) Summary page 1.

## Most influential descendants
- K101322: Joinsoon Electronics MFG CO., LTD Infrared Ear Thermometer, Model TT-001 (2010), 0 descendants of its own

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

Source page: https://510kreport.com/device/K030299
Methodology: https://510kreport.com/methodology