Cleared Traditional

K003326 - FUNET AMY MAMA BODY THERMOMETER

K003326 is an FDA 510(k) clearance for FUNET AMY MAMA BODY THERMOMETER, manufactured by Funai Radio & Communications Corp.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K003326 · Funai Radio & Communications Corp. · General Hospital
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Apr 2001
Decision
169d
Days
Class 2
Risk

K003326 is an FDA 510(k) clearance for the FUNET AMY MAMA BODY THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Funai Radio & Communications Corp. (Taichung, TW). The FDA issued a Cleared decision on April 11, 2001 after a review of 169 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K003326

510(k) Number K003326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2000
Decision Date April 11, 2001
Days to Decision 169 days
Submission Type Traditional
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
40d slower than avg
Panel avg: 129d · This submission: 169d
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 787
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K003326.
GERATHERM BABYWATCH TEMPERATURE MONITOR
K001281 · Geratherm AG · Jun 2001
TEMP-A-SURE
K010866 · Homecare Technologies , Ltd. · Jun 2001
TEMP SCAN
K010383 · Tenghi Co., Ltd. · Apr 2001
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
K010462 · Avita Corporation · Apr 2001
NPAC MULTI-USE THERMOMETER, MODEL TD400
K010224 · Norm Pacific Automation Corp. · Mar 2001
MODEL THERMO TEK QUICKCARE
K010502 · Saat , Ltd. · Feb 2001
K003326 · FUNET AMY MAMA BODY THERMOMETER
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