Cleared Traditional

K090031 - ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES

Also marketed or referenced as:
PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010

K090031 is an FDA 510(k) clearance for ACTHERM INFRARED EAR THERMOMETER, manufactured by Actherm, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K090031 · Actherm, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
101d
Days
Class 2
Risk

K090031 is an FDA 510(k) clearance for the ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Actherm, Inc. (Hsinchu, TW). The FDA issued a Cleared decision on April 16, 2009 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Actherm, Inc. devices

FDA 510(k) Submission Details - K090031

510(k) Number K090031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2009
Decision Date April 16, 2009
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 407
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K090031.
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
K091676 · Omron Healthcare, Inc. · Sep 2009
MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1
K091589 · Microlife Intellectual Property GmbH · Jun 2009
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1
K091040 · Microlife Intellectual Property GmbH · May 2009
FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E
K090395 · Taidoc Technology Corporation · Mar 2009
FORA IR22 EAR THERMOMETER, MODEL TD-1262
K090294 · Taidoc Technology Corporation · Feb 2009
TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER
K083299 · Taidoc Technology Corporation · Dec 2008