Atlas FDA

KYA

5 FDA 510(k) clearances · Product code

110 daysmedian time to decision
312 days90th percentile
5clearances measured

FDA profile

Official device name
System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
Device class
Class I (low risk)
Regulation
21 CFR 884.2982
Medical specialty
Obstetrics/Gynecology
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RecordFirmDate
VARICOSCREEN(TM) (K900404)Promedex, Inc.1990-12-07
BREAST THERMAL ACTIVITY INDICATOR (K832989)Bcsi Laboratories, Inc.1984-01-17
THERMAX; THERMAX SYSTEM (K823245)American Thermometer Company, Inc.1982-11-16
CHIROPRATIC INFRA-RED CRYSTAL PAK (K821524)Dr. John D. Reid B.A., D.C.1982-09-08
PARATHERM (K821049)American Thermometer Company, Inc.1982-04-29

Track KYA automatically

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