Atlas FDA

HHW

41 FDA 510(k) clearances · Product code

152 daysmedian time to decision
371 days90th percentile
41clearances measured

FDA profile

Official device name
Pessary, Vaginal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.3575
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2007: 4 · 2019: 15 · 2020: 401 · 2021: 24 · 2022: 14 · 2025: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes (K253698)Cooper Surgical2026-01-20
CooperSurgical Milex® Pessaries (K250438)CooperSurgical, Inc.2025-04-11
Cntrl+ Bladder Support Pessary (K240798)Cntrl+, Inc.2024-12-17
Reia pessary (K232677)Reia, LLC2024-05-21
Yoni.Fit Bladder Support (K232525)Watkins-Conti Products, Inc.2024-05-17
Uresta® (K233548)Resilia, Inc.2024-04-03
Gynethotics™ Pessary (K231786)Cosm Medical2024-03-06
ProVate Vaginal Support (K190277)Contipi Medical , Ltd.2019-07-08
Revive Reusable Bladder Support (K183468)Rinovum Subsidiary 2, LLC2019-01-25
Panpac Flexi Shelf Pessary (K173351)Panpac Medical Corporation2018-10-31
Panpac Disposable Pessary Fitting Set (K153422)Panpac Medical Corporation2016-07-14
Always/Tampax bladder supports (K151413)Procter & Gamble2015-12-18
PESSARY (K132313)Eis Corporation2014-12-05
PANPAC INFLATABLE DOCUT PESSARY (K132670)Panpac Medical Corporation2014-06-04
TIPI OTC (K131198)Contipi , Ltd.2013-08-27
PANPAC VAGINAL PESSARY (K092981)Panpac Medical Corporation2010-07-22
MODIFICATION TO URESTA PESSARY (K083769)Eastmed, Inc.2009-01-14
URESTA PESSARY (K081385)Eastmed, Inc.2008-10-09
TIPI (K060526)Contipi , Ltd.2006-06-09
KOLPEXIN SPHERE (K032644)Adamed , Ltd.2004-05-28
MARINA MEDICAL SILICONE PESSARY (K031463)Marina Medical Instruments, Inc.2003-11-18
MTI ST#1 SILICONE PESSARY (K020512)Medical Technology and Innovations, Inc.2002-05-16
PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE (K012277)Sims Portex , Ltd.2002-02-11
BIOTEQUE VAGINAL PESSARIES (K013289)Bioteque America, Inc.2001-12-27
PELVX GELLHORN VAGINAL PESSARY 603-608 (K002329)Deschutes Medical Products, Inc.2000-09-18
MENTOR EVACARE VAGINAL PESSARIES (K993308)Mentor Corp.1999-12-13
PELVX INCONTINENCE DISH, MODEL 301-306 (K990593)Deschutes Medical Products, Inc.1999-05-24
PELVX INCONTINENCE RING (K974116)Deschutes Medical Products, Inc.1998-04-27
PELVX RING, PELVX RING WITH SUPPORT (K974115)Deschutes Medical Products, Inc.1998-04-27
PELVX DONUT, PELVX CUBE (K974117)Deschutes Medical Products, Inc.1998-04-27
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL (K965040)Johnson & Johnson Medical, Inc.1997-03-10
VAGINAL CONTINENCE DEVICE (K930618)Johnson & Johnson Medical, Inc.1995-05-04
BLADDER NECK SUPPORT PROTHESIS FITTING KIT (K933654)Johnson & Johnson Medical, Inc.1995-05-04
PESSARY FLEXIBLE SILICONE DONUT RING (K920747)Bioteque America, Inc.1994-08-29
FLEXIBLE SILICONE GELIHORN (K920187)Bioteque America, Inc.1992-10-23
INGLAT-O-BALL (K904774)Milex Products, Inc.1990-12-07
INFLAT-O-BALL (K904026)Milex Products, Inc.1990-10-10
GELLHORN PESSARY 33410 VARIOUS SIZES (K890565)Medi-Source, Inc.1989-03-29
FEMALE CONTINENCE DEVICE (K883721)Cook Ob/Gyn1988-10-03
DEVICE, FEMALE INCONTINENCE (K781863)Eschmann Bros. & Walsh , Ltd.1978-11-06
SILASTIC BRAND INTRAVAGINAL TARSETTE (K771548)Dow Corning Corp. Healthcare Industries Materials1977-11-07

Track HHW automatically

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