Cleared Traditional

K100563 - GEON RAPID DIGITAL THERMOMETER MODEL: M...

K100563 is an FDA 510(k) clearance for GEON RAPID DIGITAL THERMOMETER MODEL: M..., manufactured by Geon Corporation. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K100563 · Geon Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
93d
Days
Class 2
Risk

K100563 is an FDA 510(k) clearance for the GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Geon Corporation (Flagstaff, US). The FDA issued a Cleared decision on June 2, 2010 after a review of 93 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 Geon Corporation devices

FDA 510(k) Submission Details - K100563

510(k) Number K100563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2010
Decision Date June 02, 2010
Days to Decision 93 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 129d · This submission: 93d
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 375
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K100563.
AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES
K102554 · Avita Corporation · Mar 2011
NON-CONTACT INFRARED THERMOMETER
K102947 · K-Jump Health Co., Ltd. · Feb 2011
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
K100488 · Shenzhen Dongdixin Technology Co., Ltd. · Jul 2010
U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
K100942 · Taidoc Technology Corporation · May 2010
MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
K100953 · Microlife Intellectual Property GmbH · May 2010
AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7
K100016 · Avita Corporation · Mar 2010