# K021612: Digital Clinical Thermometer, Models Act 2030, 2038

- Pathway: 510(k) (Special)
- Applicant: Actherm, Inc.
- Decided: May 30, 2002 after 14 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 K010238 (2001). 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)
- K010238: Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+, Actherm, Inc. (2001) Summary page 3.

## Most influential descendants
- K070028: Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical Thermometer (2007), 0 descendants of its own

## Indications for use
The Digital Clinical thermometers, Models ACT 2030 and ACT 2038’s intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.

Source page: https://510kreport.com/device/K021612
Methodology: https://510kreport.com/methodology