TempAlert Liquid Crystal Thermometer

by Medical Frontiers, Inc.

510(k) K850797

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K850797↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK850797	Date5 Apr 1985Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K850797
FDA Product Code: KPD

Device Class: Class II
Regulation: 21 CFR Part 880.2200
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 TempAlert Liquid Crystal Thermometer is a Temperature Strip, Forehead, Liquid Crystal, designed to detect fever or monitor body temperature changes. It operates by displaying color shifts in heat-sensitive liquid crystals when applied to the forehead, correlating with skin surface temperature variations. The device uses cholesteric esters sealed in a plastic strip to provide a visual indication of temperature.

This single-use, non-sterile device is intended for general hospital use and has been cleared under FDA 510(k) (K850797) as substantially equivalent to a predicate device. It is regulated under FDA regulation number 880.2200 and falls under device class II. The product code assigned is KPD, and it is distributed by Medical Frontiers, Inc.