# K993116: A&D Medical UT-101 Lifesource Digital Ear Therometer

- Pathway: 510(k) (Traditional)
- Applicant: A&D Engineering, Inc.
- Decided: Apr 12, 2000 after 205 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A&D Medical UT-101 LifeSource Digital Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.

Source page: https://510kreport.com/device/K993116
Methodology: https://510kreport.com/methodology