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

HED — Predicate Candidate Screening

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

106 daysmedian FDA review time

163 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K080200	WATER WORKS DOUCHING DEVICE	Abbott Research Group, Inc.	2008-07-10	167
K030056	WORRY-REMOVER IRRIGATOR	Corisen Group, Ltd.	2003-04-22	106
K000736	LA JOIE	Goomi Ehwa, Inc.	2000-08-08	154
K902830	PERI-BOTTLE	Orion Life Systems, Inc.	1990-08-06	39
K881216	GENT-L-KARE VAGINAL IRRIGATION SET	Geneva Laboratories, Inc.	1988-06-07	77
K854595	P.A. MEDICAL VAGINAL IRRIGATION SET #1130	Pa Medical Corp.	1986-01-13	56
K841710	MAC LEE VAGINAL IRRIGATOR	Mac Lee Medical Products	1984-06-19	56
K831667	FEMININE HYGIENE DEVICE	Snow Willow Co.	1983-09-12	112
K800954	DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID	The Healthcare Group Laboratories, Inc.	1980-10-03	163
K800956	DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN	The Healthcare Group Laboratories, Inc.	1980-10-03	163
K800957	DOUCHE UNIT-1500 ML DISP. CONTAINER	The Healthcare Group Laboratories, Inc.	1980-07-14	82
K781207	DOUCHE KIT, SOMETHING PERSONAL	Chatten Drug & Chemical Co.	1978-08-10	27

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