# K100660: Infrared Ear Thermometer Model DR. Schven Ict-1000

- Pathway: 510(k) (Traditional)
- Applicant: Innochips Technology Co., Ltd.
- Decided: Oct 22, 2010 after 228 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Infrared Ear Thermometer (Dr. Schven ICT-10OO) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.

Source page: https://510kreport.com/device/K100660
Methodology: https://510kreport.com/methodology