# Actherm, Inc.

- Location (FDA's records): Hsinchu, TW
- FDA decisions: 8 (2001–2010): 8 510(k) clearances
- Product codes: FLL (8)
- Predicates its devices cite: 10 (6 its own); citations of its devices by later devices: 8 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Braun GmbH: 1 (https://510kreport.com/company/braun)
- Lumiscope Co., Inc.: 1 (https://510kreport.com/company/lumiscope)
- Banta Healthcare Group, Ltd.: 1 (https://510kreport.com/company/banta-healthcare-group)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)

## Firms that cite its devices most
- Famidoc Technology Co., Ltd.: 1 (https://510kreport.com/company/famidoc-technology)
- Innovatech, Inc.: 1 (https://510kreport.com/company/innovatech)

## Its most-cited devices
- K010238: Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ (2001), cited by 4
- K031905: Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136, and Act 3030 (2003), cited by 1
- K090031: Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear Thermometer, Model MEDACCU2010 (2009), cited by 1
- K021612: Digital Clinical Thermometer, Models Act 2030, 2038 (2002), cited by 1
- K021614: Digital Clinical Thermometer, Model Act 3020 (2002), cited by 1

## Recent decisions
- K093795: Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010 (Mar 12, 2010)
- K083419: Actherm Digital Clinical Thermometer Probe Covers, Model (S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 (Jul 16, 2009)
- K090031: Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear Thermometer, Model MEDACCU2010 (Apr 16, 2009)
- K070028: Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical Thermometer (Feb 8, 2007)
- K031905: Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136, and Act 3030 (Jul 7, 2003)
- K021612: Digital Clinical Thermometer, Models Act 2030, 2038 (May 30, 2002)
- K021614: Digital Clinical Thermometer, Model Act 3020 (May 30, 2002)
- K010238: Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ (Feb 6, 2001)

Source page: https://510kreport.com/company/actherm