# K090031: Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear Thermometer, Model MEDACCU2010

- Pathway: 510(k) (Traditional)
- Applicant: Actherm, Inc.
- Decided: Apr 16, 2009 after 101 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: 1 generation back to K031928 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031928: Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt 4000 Series (Home Use Environment), Braun GmbH (2003) Summary page 1.

## Most influential descendants
- K093795: Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010 (2010), 0 descendants of its own

## Indications for use
Actherm Infrared Ear Thermometers ACT8000 Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on people of all age, and is used with or without probe cover medACCU2010.

Source page: https://510kreport.com/device/K090031
Methodology: https://510kreport.com/methodology