Product Code: KPD FDA class 2 21 CFR 880.2200

Strip, Temperature, Forehead, Liquid Crystal

General Hospital

This device is a liquid crystal forehead temperature strip used to provide a non-invasive, approximate measurement of body temperature by detecting heat at the skin surface. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device. The product code is KPD, regulated under 21 CFR 880.2200 within the General Hospital specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: KPD
Device Class: FDA class 2
Regulation Number: 880.2200
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 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K934941	E-Z TEMP II	Jul 27, 1994	Substantially Equivalent	Seven C'S, Inc.
K903307	TEMP MARQ TEMPERATURE TREND INDICATOR	Aug 17, 1990	Substantially Equivalent	Marquest Medical Products, Inc.
K893803	FEVER LINE AND FEVER LINE PLUS	Aug 21, 1989	Substantially Equivalent	Liquid Crystal Sciences, Inc.
K864853	OMNI THERM TEMPERATURE MONITOR	Feb 04, 1987	Substantially Equivalent	Omni Therm, Inc.
K850797	TEMPALERT LIQUID CRYSTAL THERMOMETER	Apr 05, 1985	Substantially Equivalent	Medical Frontiers, Inc.
K841913	TEMPTREND PEDS AXILLARY TEMP. INDICATOR	Nov 02, 1984	Substantially Equivalent	Biosynergy, Inc.
K833904	TEMPTREND II	Dec 27, 1983	Substantially Equivalent	Biosynergy, Inc.
K832651	ATI FOREHEAD THERMOMETER	Oct 04, 1983	Substantially Equivalent	American Thermal Instruments, Inc.
K823221	ACCA-TEMP SKIN TEMP. VINYL DISC	Jan 12, 1983	Substantially Equivalent	T. G. & E. Medical
K821312	TEMPTREND TEMPERATURE TREND INDICATOR	May 28, 1982	Substantially Equivalent	Liquid Crystal Products, Inc.
K820426	TEMPERATURE TREND INDICATOR (TTI)	Mar 08, 1982	Substantially Equivalent	Mon-A-Therm, Inc.
K813199	SKIN TEMPERATURE SENSING VINYL STRIP	Mar 05, 1982	Substantially Equivalent	T. G. & E. Medical
K802778	LIQUID CRYSTAL THERM. 8 EVENT MONITOR	Jan 09, 1981	Substantially Equivalent	Djinnii Industires, Inc.
K802897	ELECTRONIC DIGITAL THERMOMETER	Dec 16, 1980	Substantially Equivalent	Philip J. Teders
K790532	FEVER TESTER	May 29, 1979	Substantially Equivalent	Maddak, Inc.
K780580	TEMPERATURE INDICATOR	Apr 27, 1978	Substantially Equivalent	Respiratory Care, Inc.
K780260	TEMP. SENSOR W/22MM FITTINGS	Mar 14, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K771980	FEVER TESTER	Nov 02, 1977	Substantially Equivalent	American Thermometer Company, Inc.
K770517	NF DEVICE	Jul 15, 1977	Substantially Equivalent	Rpr, Inc.
K770353	DISPOSABLE TEMPERATURE PROBE	Mar 16, 1977	Substantially Equivalent	Inhal-O-Tech Medical Plastic
K760683	ALARM, THERMAL, THERM-ALERT	Sep 27, 1976	Substantially Equivalent	Respiratory Care, Inc.