Cleared Traditional

K003223 - GEON DIGITAL CLINICAL THERMOMETER

K003223 is an FDA 510(k) clearance for GEON DIGITAL CLINICAL THERMOMETER, manufactured by Geon Corp.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K003223 · Geon Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
88d
Days
Class 2
Risk

K003223 is an FDA 510(k) clearance for the GEON DIGITAL CLINICAL THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Geon Corp. (Flaggstaff, US). The FDA issued a Cleared decision on January 12, 2001 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K003223

510(k) Number K003223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2000
Decision Date January 12, 2001
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
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 716
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K003223.
MODEL THERMO TEK QUICKCARE
K010502 · Saat , Ltd. · Feb 2001
THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
K002712 · Saat , Ltd. · Feb 2001
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+
K010238 · Actherm, Inc. · Feb 2001
FILAC FAS TEMP ELECTRONIC THERMOMETER
K003313 · The Kendall Company · Jan 2001
AVITA TSO/TS1 INFRARED EAR THERMOMETER
K002182 · Avita Corporation · Dec 2000
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1
K003308 · Microlife Corp. · Nov 2000
K003223 · GEON DIGITAL CLINICAL THERMOMETER
Download PDF FDA Summary Geon Corp.