Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HDY — Predicate Candidate Screening

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

101 daysmedian FDA review time

198 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K040625	ATAD ARD CATHETER	Atad Developments , Ltd.	2005-01-18	315
K021012	LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM	Quality Medical Solusions, LLC	2002-06-25	88
K011512	MMODIFICATION TO LAMINARIA	A & A Medical, Inc.	2001-07-09	54
K955072	LAMINARIA	Cti Corp., Ltd.	1996-05-22	198
K892220	LAMINARIA TENT	Berkeley Medevices	1989-06-14	72
K881295	LAMINARIA CUREX	Harold W. Berger Co.	1988-08-10	135
K881312	LAMINARIA	Busse Hospital Disposables, Inc.	1988-05-23	56
K880196	LAMINARIA	Medgyn Products, Inc.	1988-05-06	101
K845006	SUN MEDICAL LAMINARIA CERVICAL DILATOR	Sun Medical, Inc.	1985-05-01	126
K833068	LAMINARIA JAPONICA CERVICAL DILATOR	Medi-Spec	1984-02-04	149
K782067	DILATOR, MIZUTANI LAMINARIA TENT	British Marketing Ent., Ltd.	1979-01-03	21

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