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RTM System (Remote Temperature Monitor)

by Remote Technologies, Inc.

510(k) K801423

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 NumberK801423 Date27 Aug 1980ClearedStatusActive

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  • Withdrawn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, 28 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 RTM System (Remote Temperature Monitor) is a device designed for remote temperature monitoring. It is used to monitor temperature conditions for medicines, vaccines, and samples.

The system is supplied by Remote Technologies, Inc. and has FDA 510(k) clearance under K number K801423. It is classified under product code FLL and was cleared on August 27, 1980.

Other devices from Remote Technologies, Inc.

  • The Remote

    Class II

Questions

AI-generated answers, 28 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 RTM System used for?

    The RTM System (Remote Temperature Monitor) is designed for remote temperature monitoring and is used to monitor temperature conditions for medicines, vaccines, and samples, ensuring proper storage and handling of temperature-sensitive materials.

  • Who manufactures the RTM System and what is its FDA authorization?

    The RTM System is manufactured by Remote Technologies, Inc. and has FDA 510(k) clearance under K number K801423, indicating it was found substantially equivalent to a legally marketed device.

  • When was the RTM System cleared by the FDA and under what product code?

    The RTM System was cleared by the FDA on August 27, 1980, under product code FLL, which corresponds to general hospital devices used for general hospital purposes, based on its traditional 510(k) submission.