Cleared Special

K021612 - DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038

K021612 is an FDA 510(k) clearance for DIGITAL CLINICAL THERMOMETER, manufactured by Actherm, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 14-day FDA review.

K021612 · Actherm, Inc. · General Hospital
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May 2002
Decision
14d
Days
Class 2
Risk

K021612 is an FDA 510(k) clearance for the DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038. 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 May 30, 2002 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K021612

510(k) Number K021612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2002
Decision Date May 30, 2002
Days to Decision 14 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 697
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K021612.
DIGITAL CLINICAL THERMOMETER, MODEL KD-193
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K020433 · Idt Technology Limited · Jul 2002
MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER
K021601 · Duteck Industrial Co., Ltd. · Jul 2002
DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020
K021614 · Actherm, Inc. · May 2002
HIVOX EAR THERMOMETER, TS SERIES
K020471 · Hivox Biotek, Inc. · May 2002
THERMOMETER MODELS ST8631
K021048 · Z7 International · Apr 2002
K021612 · DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038
Download PDF Actherm, Inc.