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Cardicare Model Mt-301F & Mt-301C

by Lumiscope Co., Inc. 510(k)

Active United States

510(k) K032714

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032714 Date22 Oct 2003ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cardicare Model MT-301F & MT-301C Thermometers are classified as Continuous Measurement Thermometers under FDA regulation 880.2910. These devices are designed for accurate measurement of body temperature via oral, axillary, and rectal routes, providing precise readings for clinical and home use.

Intended for single-use or reusable applications in general hospital settings, these thermometers are regulated under FDA 510(k) clearance (K032714) with a Traditional clearance type. They are supplied sterile or non-sterile depending on the intended use case, adhering to FDA compliance standards for medical-grade thermometry.

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