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Clinical Mercury Thermometer

by Cypress Medical Products, Ltd.

510(k) K897054

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK897054 Date22 Mar 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
FLK
Device Class
Class II
Regulation
21 CFR Part 880.2920
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Clinical Mercury Thermometer is a Class II medical device designed to measure body temperature via the thermal expansion of mercury. It is intended for oral, rectal, or axillary (armpit) use in clinical settings to provide accurate temperature readings for patient assessment.

This device is supplied as a reusable, non-sterile instrument and is regulated under the FDA’s 510(k) clearance process (K897054) under the product code FLK and regulation number 21 CFR 880.2920. It is intended for general hospital use and adheres to standard mercury-based thermometry principles without additional sterilization requirements. No MRI safety information is specified.

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Questions

AI-generated answers, 1 Oct 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 Clinical Mercury Thermometer used for?

    It is intended for measuring body temperature via oral, rectal, or axillary (armpit) use in clinical settings to support patient assessment through mercury thermal expansion.

  • Is the Clinical Mercury Thermometer sterile or single-use?

    The device is supplied as a reusable, non-sterile instrument and is not intended for single-use; it requires cleaning between uses per standard clinical protocols.

  • How is the Clinical Mercury Thermometer supplied and regulated?

    It is supplied as a reusable thermometer and regulated under FDA 510(k) clearance K897054 under product code FLK and regulation 21 CFR 880.2920 as a Class II device.