# K003308: Microlife Digital Infrared Ear Thermometer, IR1DAI, IR1DB1, IR1DD1

- Pathway: 510(k) (Special)
- Applicant: Microlife Corp.
- Decided: Nov 14, 2000 after 22 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.
33 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020725: Microlife Digital Infrared Ear Thermometer, Model IR1DE1 (2002), 31 descendants of its own
- K033820: Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 (2004), 23 descendants of its own
- K100953: Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1 (2010), 18 descendants of its own
- K191829: Microlife Non-Contact Infrared Forehead Thermometer (2020), 11 descendants of its own
- K034023: Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 (2004), 6 descendants of its own

Source page: https://510kreport.com/device/K003308
Methodology: https://510kreport.com/methodology