ACTHERM DIGITAL CLINICAL THERMOMETER - ACT2010

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K010238 ↗

FDA Product Code

FLL

Models / Variants

ACT2000

ACT2010

ACT2000+

ACT2010+

ACT2020+

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010

  Class II

  FDA 510(k) K093795 Active Cleared 12 Mar 2010

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

  Class II

  FDA 510(k) K070028 Active Cleared 8 Feb 2007

• Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136, and Act 3030

  Class II

  FDA 510(k) K031905 Active Cleared 7 Jul 2003

• Actherm Digital Clinical Thermometer Probe Covers, Model(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020

  Class II

  FDA 510(k) K083419 Active Cleared 16 Jul 2009

• Digital Clinical Thermometer, Model Act 3020

  Class II

  FDA 510(k) K021614 Active Cleared 30 May 2002

• Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear Thermometer, Model MEDACCU2010

  Class II

  FDA 510(k) K090031 Active Cleared 16 Apr 2009

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