Atlas FDA

KPD

21 FDA 510(k) clearances · Product code

43 daysmedian time to decision
119 days90th percentile
21clearances measured

FDA profile

Official device name
Strip, Temperature, Forehead, Liquid Crystal
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2200
Medical specialty
General Hospital
Adverse events (MAUDE)
1993: 1 · 1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
E-Z TEMP II (K934941)Seven C'S, Inc.1994-07-27
TEMP MARQ TEMPERATURE TREND INDICATOR (K903307)Marquest Medical Products, Inc.1990-08-17
FEVER LINE AND FEVER LINE PLUS (K893803)Liquid Crystal Sciences, Inc.1989-08-21
OMNI THERM TEMPERATURE MONITOR (K864853)Omni Therm, Inc.1987-02-04
TEMPALERT LIQUID CRYSTAL THERMOMETER (K850797)Medical Frontiers, Inc.1985-04-05
TEMPTREND PEDS AXILLARY TEMP. INDICATOR (K841913)Biosynergy, Inc.1984-11-02
TEMPTREND II (K833904)Biosynergy, Inc.1983-12-27
ATI FOREHEAD THERMOMETER (K832651)American Thermal Instruments, Inc.1983-10-04
ACCA-TEMP SKIN TEMP. VINYL DISC (K823221)T. G. & E. Medical1983-01-12
TEMPTREND TEMPERATURE TREND INDICATOR (K821312)Liquid Crystal Products, Inc.1982-05-28
TEMPERATURE TREND INDICATOR (TTI) (K820426)Mon-A-Therm, Inc.1982-03-08
SKIN TEMPERATURE SENSING VINYL STRIP (K813199)T. G. & E. Medical1982-03-05
LIQUID CRYSTAL THERM. 8 EVENT MONITOR (K802778)Djinnii Industires, Inc.1981-01-09
ELECTRONIC DIGITAL THERMOMETER (K802897)Philip J. Teders1980-12-16
FEVER TESTER (K790532)Maddak, Inc.1979-05-29
TEMPERATURE INDICATOR (K780580)Respiratory Care, Inc.1978-04-27
TEMP. SENSOR W/22MM FITTINGS (K780260)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-03-14
FEVER TESTER (K771980)American Thermometer Company, Inc.1977-11-02
NF DEVICE (K770517)Rpr, Inc.1977-07-15
DISPOSABLE TEMPERATURE PROBE (K770353)Inhal-O-Tech Medical Plastic1977-03-16
ALARM, THERMAL, THERM-ALERT (K760683)Respiratory Care, Inc.1976-09-27

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Every clearance here is in the API, with alerts when new ones post.