Cleared Traditional

K032714 - CARDICARE MODEL MT-301F & MT-301C

K032714 is an FDA 510(k) clearance for CARDICARE MODEL MT-301F & MT-301C, manufactured by Lumiscope Co., Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K032714 · Lumiscope Co., Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
50d
Days
Class 2
Risk

K032714 is an FDA 510(k) clearance for the CARDICARE MODEL MT-301F & MT-301C. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Lumiscope Co., Inc. (East Brunswick, US). The FDA issued a Cleared decision on October 22, 2003 after a review of 50 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 - K032714

510(k) Number K032714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2003
Decision Date October 22, 2003
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 787
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K032714.
AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
K031503 · Avita Corporation · Oct 2003
BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT)
K031928 · Braun GmbH · Oct 2003
DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205
K033069 · Tenghi Co., Ltd. · Oct 2003
MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932)
K032364 · Microlife Intellectual Property GmbH · Sep 2003
MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER
K032658 · Microlife Intellectual Property GmbH · Sep 2003
NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351
K031907 · Norm Pacific Automation Corp. · Aug 2003
K032714 · CARDICARE MODEL MT-301F & MT-301C
Download PDF FDA Summary Lumiscope Co., Inc.