# K081061: Harvard Medical Devices IR Ear Thermometer, Models Hmiret-002 and Kinetik Branded IET1 Series

- Pathway: 510(k) (Traditional)
- Applicant: Harvard Medical Devices, Ltd.
- Decided: Jul 18, 2008 after 95 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
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in neonatal, pediatric and adult population used in the home setting.

Source page: https://510kreport.com/device/K081061
Methodology: https://510kreport.com/methodology