Cleared Special

K051233 - OMRON MODEL 514N TYMPANIC THERMOMETER

K051233 is the FDA 510(k) clearance for OMRON MODEL 514N TYMPANIC THERMOMETER by Omron Healthcare, Inc.. It is a Class 2 General Hospital device (product code FLL) cleared through the Special 510(k) pathway after a 39-day FDA review.

K051233 · Omron Healthcare, Inc. · General Hospital
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Jun 2005
Decision
39d
Days
Class 2
Risk

K051233 is an FDA 510(k) clearance for the OMRON MODEL 514N TYMPANIC THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Omron Healthcare, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on June 21, 2005 after a review of 39 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.

View all Omron Healthcare, Inc. devices

Submission Details

510(k) Number K051233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2005
Decision Date June 21, 2005
Days to Decision 39 days
Submission Type Special
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
90d faster than avg
Panel avg: 129d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 317
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K051233.
ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS
K060173 · ACON Laboratories, Inc. · Mar 2006
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · Ge Healthcare · Sep 2005
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER
K050463 · Taidoc Technology Corporation · Jul 2005
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
K051100 · Microlife Intellectual Property GmbH · May 2005
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837 · Ge Healthcare · Apr 2005
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
K043110 · Microlife Intellectual Property GmbH · Dec 2004