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

HHW — Predicate Candidate Screening

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

152 daysmedian FDA review time

371 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253698	Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish	Cooper Surgical	2026-01-20	57	0
K250438	CooperSurgical Milex® Pessaries	CooperSurgical, Inc.	2025-04-11	56	0
K240798	Cntrl+ Bladder Support Pessary	Cntrl+, Inc.	2024-12-17	270	0
K232677	Reia pessary	Reia, LLC	2024-05-21	263	0
K232525	Yoni.Fit Bladder Support	Watkins-Conti Products, Inc.	2024-05-17	270	0
K233548	Uresta®	Resilia, Inc.	2024-04-03	152	0
K231786	Gynethotics™ Pessary	Cosm Medical	2024-03-06	260	0
K190277	ProVate Vaginal Support	Contipi Medical , Ltd.	2019-07-08	150	0
K183468	Revive Reusable Bladder Support	Rinovum Subsidiary 2, LLC	2019-01-25	42	0
K173351	Panpac Flexi Shelf Pessary	Panpac Medical Corporation	2018-10-31	371	0
K153422	Panpac Disposable Pessary Fitting Set	Panpac Medical Corporation	2016-07-14	232	0
K151413	Always/Tampax bladder supports	Procter & Gamble	2015-12-18	205	0
K132313	PESSARY	Eis Corporation	2014-12-05	498	0
K132670	PANPAC INFLATABLE DOCUT PESSARY	Panpac Medical Corporation	2014-06-04	281	0
K131198	TIPI OTC	Contipi , Ltd.	2013-08-27	123	0
K092981	PANPAC VAGINAL PESSARY	Panpac Medical Corporation	2010-07-22	297	0
K083769	MODIFICATION TO URESTA PESSARY	Eastmed, Inc.	2009-01-14	27	0
K081385	URESTA PESSARY	Eastmed, Inc.	2008-10-09	146	0
K060526	TIPI	Contipi , Ltd.	2006-06-09	102	0
K032644	KOLPEXIN SPHERE	Adamed , Ltd.	2004-05-28	275	0
K031463	MARINA MEDICAL SILICONE PESSARY	Marina Medical Instruments, Inc.	2003-11-18	194	0
K020512	MTI ST#1 SILICONE PESSARY	Medical Technology and Innovations, Inc.	2002-05-16	90	0
K012277	PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POL	Sims Portex , Ltd.	2002-02-11	207	0
K013289	BIOTEQUE VAGINAL PESSARIES	Bioteque America, Inc.	2001-12-27	86	0
K002329	PELVX GELLHORN VAGINAL PESSARY 603-608	Deschutes Medical Products, Inc.	2000-09-18	48	0
K993308	MENTOR EVACARE VAGINAL PESSARIES	Mentor Corp.	1999-12-13	70	0
K990593	PELVX INCONTINENCE DISH, MODEL 301-306	Deschutes Medical Products, Inc.	1999-05-24	89	0
K974116	PELVX INCONTINENCE RING	Deschutes Medical Products, Inc.	1998-04-27	178	0
K974115	PELVX RING, PELVX RING WITH SUPPORT	Deschutes Medical Products, Inc.	1998-04-27	178	0
K974117	PELVX DONUT, PELVX CUBE	Deschutes Medical Products, Inc.	1998-04-27	178	0
K965040	INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL	Johnson & Johnson Medical, Inc.	1997-03-10	83	0
K930618	VAGINAL CONTINENCE DEVICE	Johnson & Johnson Medical, Inc.	1995-05-04	815	0
K933654	BLADDER NECK SUPPORT PROTHESIS FITTING KIT	Johnson & Johnson Medical, Inc.	1995-05-04	646	0
K920747	PESSARY FLEXIBLE SILICONE DONUT RING	Bioteque America, Inc.	1994-08-29	922	0
K920187	FLEXIBLE SILICONE GELIHORN	Bioteque America, Inc.	1992-10-23	283	0
K904774	INGLAT-O-BALL	Milex Products, Inc.	1990-12-07	46	14
K904026	INFLAT-O-BALL	Milex Products, Inc.	1990-10-10	41	12
K890565	GELLHORN PESSARY 33410 VARIOUS SIZES	Medi-Source, Inc.	1989-03-29	51	0
K883721	FEMALE CONTINENCE DEVICE	Cook Ob/Gyn	1988-10-03	33	0
K781863	DEVICE, FEMALE INCONTINENCE	Eschmann Bros. & Walsh , Ltd.	1978-11-06	0	0
K771548	SILASTIC BRAND INTRAVAGINAL TARSETTE	Dow Corning Corp. Healthcare Industries Materials	1977-11-07	87	0

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