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Temperature Trend Indicator (TTI)

by Mon-A-Therm, Inc.

510(k) K820426

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 NumberK820426 Date8 Mar 1982ClearedStatusActive

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  • Withdrawn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
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 Temperature Trend Indicator (TTI) is a liquid crystal strip designed to monitor temperature trends, specifically for use in general hospital settings. It visually indicates temperature fluctuations, aiding in the assessment of thermal conditions during medical procedures or patient care.

The TTI is supplied as a single-use strip and is regulated under FDA 510(k) clearance (K820426) as a Class 2 device with product code KPD. It is intended for use in environments requiring temperature monitoring, such as patient care areas, and adheres to regulatory standards outlined in 21 CFR 880.2200. No third-party review or combination product designation applies.

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Questions

AI-generated answers, 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.

  • What is the Temperature Trend Indicator (TTI) used for?

    The TTI is a liquid crystal strip designed to monitor temperature trends in general hospital settings, helping to visually indicate temperature fluctuations during medical procedures or patient care.

  • Is the TTI a single-use or reusable device?

    The TTI is supplied as a single-use strip, meaning it should be discarded after one use to ensure accurate temperature monitoring and maintain hygiene standards.

  • What regulatory standards apply to the TTI?

    The TTI is regulated under FDA 510(k) clearance (K820426) as a Class 2 device with product code KPD, adhering to regulatory standards outlined in 21 CFR 880.2200.

  • How is the TTI supplied and stored?

    The TTI is supplied as a single-use strip, but specific storage requirements are not detailed in the provided information.