Product Code: FLK FDA class 2 21 CFR 880.2920

Thermometer, Clinical Mercury

General Hospital

The Clinical Mercury Thermometer is a traditional glass thermometer containing mercury used to measure oral, rectal, or axillary body temperature in patients. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FLK, regulated under 21 CFR 880.2920 in the General Hospital specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: FLK
Device Class: FDA class 2
Regulation Number: 880.2920
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K960185	AMSINO CLINICAL THERMOMETER	Mar 28, 1996	Substantially Equivalent	Amsia Intl., Inc.
K960224	GERATHERM MERCUIRY FREE CLINICAL THERMOMETER	Mar 25, 1996	Substantially Equivalent	Rg Ent., Inc.
K953465	KENTEMP	Dec 15, 1995	Substantially Equivalent	Kentron Health Care, Inc.
K942483	CLINICAL GLASS THERMOMETER	Mar 28, 1995	Substantially Equivalent	Makol Medical Instruments Corp.
K941673	MEDIAID UNIVERSAL THERMOMETER	Aug 25, 1994	Substantially Equivalent	Polymedica Industries, Inc.
K940394	AMG MED BRAND CLINICAL GLASS THERMOMETER	May 04, 1994	Substantially Equivalent	Technolab Industries (Canada) , Ltd.
K940380	AMG MED BRAND CLINICAL GLASS THERMOMETER	May 04, 1994	Substantially Equivalent	Amg Medical, Inc.
K932991	GUARDIAN AND ANDINO MODELS	Jan 28, 1994	Substantially Equivalent	Coltemp, Inc.
K923225	LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME	Jun 08, 1993	Substantially Equivalent	Lorrex Health Products
K913793	SIMPEX INC. ORAL AND RECTAL THERMOMETERS	Dec 30, 1991	Substantially Equivalent	Simpex, Inc.
K911269	MERCURY AND GLASS FEVER THERMOMETER	May 15, 1991	Substantially Equivalent	Steridyne Corp.
K902625	CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT	Oct 26, 1990	Substantially Equivalent	Liaoning-Usa Corp.
K903500	MASCOT THERMOTER	Oct 09, 1990	Substantially Equivalent	Mascot, Inc.
K901790	THERMOMETER, MERCURY/CLINICAL	Jul 11, 1990	Substantially Equivalent	Perlink USA, Inc.
K900646	MERCURY THERMOMETERS (ORAL AND RECTAL)	Jul 11, 1990	Substantially Equivalent	Abel Industries, Inc.
K897054	CLINICAL MERCURY THERMOMETER	Mar 22, 1990	Substantially Equivalent	Cypress Medical Products, Ltd.
K893602	GLASS MERCURY FILLED THERMOMETERS	Aug 08, 1989	Substantially Equivalent	Smith & Nephew United, Inc.
K883573	THERMOMETER, MERCURY/CLINICAL	Nov 07, 1988	Substantially Equivalent	Umax Corp.
K870285	THERMOMETER SHEATHES, STERILE (GLASS)	Feb 12, 1987	Substantially Equivalent	The Medical Group, Inc.
K852301	INOX THERMOMETER JAR	Jul 01, 1985	Substantially Equivalent	Broadwest Corp.
K822502	DISPOSABLE THERMOMETERS	Sep 24, 1982	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K813424	THERMOMETERS	Dec 18, 1981	Substantially Equivalent	Abco Dealers, Inc.
K813423	THERMOMETER SHEATHS	Dec 18, 1981	Substantially Equivalent	Abco Dealers, Inc.
K811631	THERMOMETER (MADE IN CHINA)	Jul 20, 1981	Substantially Equivalent	Robert I. Chien & Assoc., Inc.
K801791	FERTILITY AWARENESS METHOD KIT	Oct 31, 1980	Substantially Equivalent	Telesis Corp.
K792426	DISPOSABLE TEMPERATURE PROBE	Jan 16, 1980	Substantially Equivalent	Hospitak, Inc.
K790891	TEMPO2-II DISPOSABLE THERMOMETERS	Jun 27, 1979	Substantially Equivalent	Airlife, Inc.
K781817	OVU-GUIDE	Dec 04, 1978	Substantially Equivalent	Reproduction Research Laboratories
K781106	THERMOMETER, EXACTA TEMP	Aug 10, 1978	Substantially Equivalent	S.M.B. Celsius Co., Inc.
K780591	THERMOMETER KIT	Apr 19, 1978	Substantially Equivalent	Abco Dealers, Inc.
K772365	THERMOMETER SHEATHS	Jan 26, 1978	Substantially Equivalent	Medline Industries, Inc.
K770125	DISPOS-A-CARE THERMOMETER SHEATH	Mar 14, 1977	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K760552	THERMOMETER STAND AND DUST COVER	Nov 12, 1976	Substantially Equivalent	Landmark Plastics