# K093795: Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010

- Pathway: 510(k) (Special)
- Applicant: Actherm, Inc.
- Decided: Mar 12, 2010 after 92 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: 2 generations back to K031928 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090031: Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear Thermometer, Model MEDACCU2010, Actherm, Inc. (2009) Summary page 1.

## Indications for use
Actherm Infrared Ear Thermometers A CT 8000R Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on pcoplc of all age, and is used with or without probe cover mnedACCU2O 10.

Source page: https://510kreport.com/device/K093795
Methodology: https://510kreport.com/methodology