Cleared Traditional

K091676 - MC-245, MC-246, MC-247, MC-341, MC-343, MC-344

K091676 is an FDA 510(k) clearance for MC-245, manufactured by Omron Healthcare, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K091676 · Omron Healthcare, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
84d
Days
Class 2
Risk

K091676 is an FDA 510(k) clearance for the MC-245, MC-246, MC-247, MC-341, MC-343, MC-344. 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 September 1, 2009 after a review of 84 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 - K091676

510(k) Number K091676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2009
Decision Date September 01, 2009
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 794
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K091676.
AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES
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REMOTE INFRARED THERMOMETER, MODEL RC002
K090361 · Rycom Electron Technology Limited · Oct 2009
ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020
K083419 · Actherm, Inc. · Jul 2009
TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370
K090564 · Truly Instrument Limited · Jun 2009
MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1
K091589 · Microlife Intellectual Property GmbH · Jun 2009
K091676 · MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
Download PDF FDA Summary Omron Healthcare, Inc.