Cleared Special

K051422 - DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE

K051422 is an FDA 510(k) clearance for DUAL MODE UP-GRADE FOREHEAD/UNDERARM TH..., 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 92-day FDA review.

K051422 · Medisim, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
92d
Days
Class 2
Risk

K051422 is an FDA 510(k) clearance for the DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Medisim, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on September 1, 2005 after a review of 92 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. 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. Standard predicate reliance. 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 - K051422

510(k) Number K051422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2005
Decision Date September 01, 2005
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
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 K051422.
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · Ge Healthcare · Sep 2005
RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES
K051269 · Radiant Innovation, Inc. · Sep 2005
INFRARED EAR THEMOMETER, MODELS DX6603, DX66390
K051251 · Shenzhen Dongdixin Technology Co., Ltd. · Sep 2005
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER
K050463 · Taidoc Technology Corporation · Jul 2005
OMRON MODEL 514N TYMPANIC THERMOMETER
K051233 · Omron Healthcare, Inc. · Jun 2005
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
K051100 · Microlife Intellectual Property GmbH · May 2005
K051422 · DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
Download PDF FDA Summary Medisim, Ltd.