Cleared Special

K012217 - M5T INSTANT FEVER THERMOMETER

K012217 is an FDA 510(k) clearance for M5T INSTANT FEVER THERMOMETER, manufactured by Medisim, Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 16-day FDA review.

K012217 · Medisim, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
16d
Days
Class 2
Risk

K012217 is an FDA 510(k) clearance for the M5T INSTANT FEVER THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Medisim, Ltd. (Ra'Ananna, IL). The FDA issued a Cleared decision on August 1, 2001 after a review of 16 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 - K012217

510(k) Number K012217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date August 01, 2001
Days to Decision 16 days
Submission Type Special
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
113d faster than avg
Panel avg: 129d · This submission: 16d
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 679
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K012217.
INFRARED EAR THERMOMETER, MODELS TH88 SERIES
K020504 · Radiant Innovation, Inc. · Feb 2002
INFARED EAR THERMOMETER, MODEL TH8 SERIES
K011059 · Radiant Innovation, Inc. · Sep 2001
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
K012136 · Avita Corporation · Sep 2001
TEMPORALSCANNER THERMOMETER, SENSORTOUCH
K011291 · Exergen Corp. · Jul 2001
EAR THERMOMETER, MODELS ST613C AND ST613F
K011254 · Mesure Technology · Jul 2001
TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX
K010235 · Oriental System Technology, Inc. · Jul 2001
K012217 · M5T INSTANT FEVER THERMOMETER
Download PDF FDA Summary Medisim, Ltd.