Atlas FDA

HIO

20 FDA 510(k) clearances · Product code

88 daysmedian time to decision
258 days90th percentile
20clearances measured

FDA profile

Official device name
Sampler, Amniotic Fluid (Amniocentesis Tray)
Device class
Class I (low risk)
Regulation
21 CFR 884.1550
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
2000: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
G.E. STERILE AMNIOCENTESIS TRAY (K960203)GE Medical Systems1996-03-14
RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY (K955679)Contour Fabricators of Florida, Inc.1996-03-12
AMNIOTEST(TM) (K914419)Pro-Lab, Inc.1993-09-01
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE (K922960)Cameo, Inc.1992-11-05
SONO-VU US(TM), MODIFICATION (K921738)E-Z-Em, Inc.1992-04-27
MEGA AMNIOCENTESIS KIT (K915863)Mega Medical, Inc.1992-03-30
SONO-VU US(TM) (K904583)E-Z-Em, Inc.1991-06-24
ISOFLO(TM) AMNIOCENTESIS TRAY (K901643)Healthdyne Cardiovascular, Inc.1990-07-25
PERCU-SET(TM) (K900021)E-Z-Em, Inc.1990-03-29
AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) (K896031)Concord/Portex1990-01-12
PHARMASEAL GENETIC AMNIOCENTESIS TRAY (K894031)Baxter Healthcare Corp1989-08-04
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE (K892846)Cook Ob/Gyn1989-07-14
ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY (K890463)Critical Specialties, Inc.1989-04-07
NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE (K862365)Swemed Laboratories, Inc.1986-07-07
HURWITZ AMNIOCENTESIS NEEDLE (K854725)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-03-17
PMS AMNIOCENTESIS TRAY/KIT (K850632)Professional Medical Services1985-05-22
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE (K844558)Universal Medical Instrument Corp.1985-01-31
AMNIO CENTESES KIT W/NEEDLE (K830019)Universal Medical Instrument Corp.1983-01-18
APTEK ULTRASOUND PROCEDURE TRAY (K802666)Aptek , Ltd.1980-11-26
AMMOCENTESIS TRAY (KIT) (K761230)Pharmaseal Div., Baxter Healthcare Corp.1976-12-17

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