Skip to content

Temperature Monitor (W/Probe)

by Biotronex Laboratory, Inc.

510(k) K792257

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792257 Date4 Dec 1979ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 27 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 Temperature Monitor (W/Probe) is a device designed to provide accurate measurements of temperature. It functions as a monitoring system to track temperature variations in real-time.

This device is supplied by Biotronex Laboratory, Inc. and has received FDA 510(k) clearance. It is intended for use in general hospital settings for the maintenance of temperature-sensitive environments.

Questions

AI-generated answers, 27 Sep 2026

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

  • What is the intended use of the Biotronex Temperature Monitor?

    This device is designed for use in general hospital settings to provide accurate, real-time measurements and monitoring of temperature-sensitive environments.

  • What is the regulatory status of this temperature monitoring system?

    The Biotronex Temperature Monitor (W/Probe) has received FDA 510(k) clearance, which indicates that the device has been found substantially equivalent to a legally marketed predicate device.

  • Who is the manufacturer of this device?

    This temperature monitor is manufactured by Biotronex Laboratory, Inc., located in McHenry, Illinois.