# K042906: Amplife Digital Infrared Ear Thermometer, Model E101

- Pathway: 510(k) (Traditional)
- Applicant: Amplife Corporation
- Decided: Nov 19, 2004 after 29 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: 3 generations back to K000969 (2000). 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)
- K034023: Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1, Microlife Intellectual Property GmbH (2004) Summary page 1.

## Indications for use
The AMPLIFE Digital Infrared Ear Thermometer, Model El00, is a Digital Infrared Ear Thermometer (without probe cover) using an infrared sensor to detect body temperature from the ear in the neonatal, pediatric and adult population used in the home setting. The device is used without a probe cover.

Source page: https://510kreport.com/device/K042906
Methodology: https://510kreport.com/methodology