Cleared Special

K031905 - DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030

K031905 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 17-day FDA review.

K031905 · Actherm, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2003
Decision
17d
Days
Class 2
Risk

K031905 is an FDA 510(k) clearance for the DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, A.... 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 July 7, 2003 after a review of 17 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 - K031905

510(k) Number K031905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2003
Decision Date July 07, 2003
Days to Decision 17 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
112d faster than avg
Panel avg: 129d · This submission: 17d
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 K031905.
NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351
K031907 · Norm Pacific Automation Corp. · Aug 2003
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1
K031958 · Microlife Intellectual Property GmbH · Aug 2003
DIGITAL TEMPERATURE MONITOR
K030219 · Kang Ying Medical Appliances, Inc. · Aug 2003
VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
K031556 · Vivant Medical, Inc. · Jun 2003
SURETEMP PLUS
K030580 · Welch Allyn, Inc. · May 2003
THERMO BUDDY, MODELS TB-100, TB-110, TB-120
K023412 · Hubdic Co., Ltd. · Apr 2003
K031905 · DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030
Download PDF Actherm, Inc.