Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

HIO — Predicate Candidate Screening

20 FDA 510(k) clearances under this product code; the 50 most recent screened below.

88 daysmedian FDA review time

258 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days
K960203	G.E. STERILE AMNIOCENTESIS TRAY	GE Medical Systems	1996-03-14	58
K955679	RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY	Contour Fabricators of Florida, Inc.	1996-03-12	89
K914419	AMNIOTEST(TM)	Pro-Lab, Inc.	1993-09-01	699
K922960	VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE	Cameo, Inc.	1992-11-05	140
K921738	SONO-VU US(TM), MODIFICATION	E-Z-Em, Inc.	1992-04-27	89
K915863	MEGA AMNIOCENTESIS KIT	Mega Medical, Inc.	1992-03-30	90
K904583	SONO-VU US(TM)	E-Z-Em, Inc.	1991-06-24	258
K901643	ISOFLO(TM) AMNIOCENTESIS TRAY	Healthdyne Cardiovascular, Inc.	1990-07-25	107
K900021	PERCU-SET(TM)	E-Z-Em, Inc.	1990-03-29	86
K896031	AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)	Concord/Portex	1990-01-12	88
K894031	PHARMASEAL GENETIC AMNIOCENTESIS TRAY	Baxter Healthcare Corp	1989-08-04	59
K892846	ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE	Cook Ob/Gyn	1989-07-14	87
K890463	ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY	Critical Specialties, Inc.	1989-04-07	67
K862365	NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE	Swemed Laboratories, Inc.	1986-07-07	13
K854725	HURWITZ AMNIOCENTESIS NEEDLE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1986-03-17	115
K850632	PMS AMNIOCENTESIS TRAY/KIT	Professional Medical Services	1985-05-22	92
K844558	UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE	Universal Medical Instrument Corp.	1985-01-31	71
K830019	AMNIO CENTESES KIT W/NEEDLE	Universal Medical Instrument Corp.	1983-01-18	14
K802666	APTEK ULTRASOUND PROCEDURE TRAY	Aptek , Ltd.	1980-11-26	29
K761230	AMMOCENTESIS TRAY (KIT)	Pharmaseal Div., Baxter Healthcare Corp.	1976-12-17	7

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda