# K070028: Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical Thermometer

- Pathway: 510(k) (Special)
- Applicant: Actherm, Inc.
- Decided: Feb 8, 2007 after 36 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 K010238 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010238: Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+, Actherm, Inc. (2001) Summary page 1.
- K021612: Digital Clinical Thermometer, Models Act 2030, 2038, Actherm, Inc. (2002) Summary page 1.
- K021614: Digital Clinical Thermometer, Model Act 3020, Actherm, Inc. (2002) Summary page 1.
- K031905: Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136, and Act 3030, Actherm, Inc. (2003) Summary page 1.
- K954792: Lumiscope Model 2018 Thermometer, Lumiscope Co., Inc. (1996) Summary page 1.

## Indications for use
All Digital Clinical Thermometers are intended to precisely measure human body temperature. The Thermometers can be used in the measurement of oral, axillary and rectal temperature.

Source page: https://510kreport.com/device/K070028
Methodology: https://510kreport.com/methodology