Atlas FDA

LKY

87 FDA 510(k) clearances · Product code

100 daysmedian time to decision
225 days90th percentile
87clearances measured

FDA profile

Official device name
Device, External Penile Rigidity
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5020
Medical specialty
Gastroenterology, Urology
FDA definition
Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
NANMA VACUUM PUMP PROXZEK MODEL 2M9498S (K041573)Nanma Mfg Co., Ltd.2004-08-25
VACURECT VACUUM CONSTRICTION DEVICE (K032776)Vacurect Manufacturing (Pty) , Ltd.2003-10-03
NANMA ADJUSTABLE CONSTRICTION RING (K030119)Nanma Mfg Co., Ltd.2003-08-06
NANMA VACUUM PUMP (K030913)Nanma Mfg Co., Ltd.2003-06-03
MODIFICATION TO NANMA VACUUM PUMP (K013113)Nanma Mfg Co., Ltd.2002-12-20
NANMA ADJUSTABLE CONSTRICTION RING (K013051)Nanma Mfg Co., Ltd.2002-08-22
VACURECT VACUUM CONSTRICTION DEVICE (K020969)Vacurect Manufacturing (Pty) , Ltd.2002-06-05
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING (K013053)Nanma Mfg Co., Ltd.2002-05-09
VT-1 (K020154)Pos-T-Vac, Inc.2002-04-04
SUPPORT SLEEVE (K020258)Pos-T-Vac, Inc.2002-04-04
ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM (K020082)Endocare, Inc.2002-02-05
SE-100 VACUUM ERECTION DEVICE (K012662)Vts, Inc.2001-11-09
BOSS 2000-3 VACUUM ERECTION DEVICE (K012670)Pos-T-Vac, Inc.2001-11-09
VT-1 (K012619)Vts, Inc.2001-11-09
BOSS-2000-2 VACUUM ERECTION DEVICE (K012672)Pos-T-Vac, Inc.2001-11-09
SE-300 VACUUM THERAPY SYSTEM (K012639)Vts, Inc.2001-11-09
SE-200 (K012620)Vts, Inc.2001-11-09
PENILE CONSTRICTOR RING (K001859)Basic Solutions, LLC2001-01-11
ACTIS ADJUSTABLE CONSTRICTION LOOP (K003115)Vivus, Inc.2000-12-19
IMPOAID (K000730)Impoaid, Inc.2000-10-19
NANMA VACUUM PUMP (K993909)Nanma Mfg Co., Ltd.2000-07-19
SENSATION -VACUUM ASSIST DEVICES (K000124)Prosurg, Inc.2000-07-10
ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS (K993343)Erecxel Enterprises2000-03-20
NANMA NON-ADJUSTABLE CONSTRICTION RING (K993906)Nanma Mfg Co., Ltd.2000-01-31
NANMA AJUSTABLE CONSTRICTION RING (K993908)Nanma Mfg Co., Ltd.2000-01-31
ELITE CUSTOM (K993142)Soma Blue, Inc.1999-12-27
VITALITY SYSTEM (K993143)Soma Blue, Inc.1999-12-27
V.T.S., INC. (V.T.-3) (K992442)Vts, Inc.1999-10-05
ERCO-RIBBON -C (K990008)Ercons, Inc.1999-02-24
ERCO-VAC -C (K990006)Ercons, Inc.1999-02-24
MAX IT (K983438)Dorea, Inc.1999-02-08
RAPPORT V.T.D. (K982275)Owen Mumford USA, Inc.1998-12-04
ERCO-RIBBON (K981343)Ercons, Inc.1998-11-24
ERCO-VAC (K981357)Ercons, Inc.1998-11-24
POS-T-VAC (AVP-1000) (K983245)Pos-T-Vac, Inc.1998-11-02
POS-T-VAC (IVP-600) (K983246)Pos-T-Vac, Inc.1998-11-02
POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) (K981011)Pos-T-Vac, Inc.1998-08-28
REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT (K981180)Pos-T-Vac, Inc.1998-08-28
VED VALU- VACUUM ERECTION DEVICE (K980948)Mission Pharmacal Comp1998-06-25
RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) (K981506)Repro-Med Systems, Inc.1998-06-25
MEGAVAC SYSTEM (K974196)Barry J. Kaplan, Inc.1998-05-12
XTEND (K980752)Walling Medical Equipment Co.1998-05-06
CHARGER (ED) (K980567)Walling Medical Equipment Co.1998-05-06
IMPOWER EXTERNAL VACUUM SYSTEM (K980291)Imagyn Medical Technologies, Inc.1998-03-11
THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE (K974082)Performance Plus, Inc.1998-02-27
ERECAID SYSTEM/STAY EREC SYSTEM (K974173)Imagyn Medical Technologies, Inc.1998-02-25
VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET (K974215)Vetco, Inc.1998-02-19
VTU-E VACUUM ERECTION SYSTEM (K974470)Encore, Inc.1998-01-09
ERCO-VAC (K972537)Ercons, Inc.1997-11-03
ERCO-RIBBON (K972353)Ercons, Inc.1997-10-28
REJOYN PENILE SUPPORT SYSTEM (K971576)American Medtech1997-10-16
VTU-1 VACUUM ERECTION SYSTEM (K971257)Mckenna & Cuneo1997-10-03
RELIANT CHARGER (K971768)Walling Medical Equipment Co.1997-09-29
RAPPORT V.T.D. (K971443)Owen Mumford USA, Inc.1997-09-26
ACTIS (VENOUS FLOW CONTROLLER) (K962915)Vivus, Inc.1996-12-10
POS-T-VAC B-10 BAND KIT (K960828)Pos-T-Vac, Inc.1996-03-08
POS-T-VAC AVP-1000 & MVP-700 (K960342)Pos-T-Vac, Inc.1996-03-01
TEX-AID BLUE (K955856)Laborie Medical Technologies, Ltd.1996-02-16
POS-T-VAC-AVP-1000 (K941087)Pos-T-Vac, Inc.1994-07-25
RELIANT CONSTRICTION RING (K940995)Walling Medical Equipment Co.1994-06-14
RELIANT (K932397)Allan Walling Medical Equipment Co.1994-03-07
DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE (K920409)Dacomed Corp.1992-05-11
ECONOAID (K914557)Gromedco1992-01-23
ERECAID(R) SYSTEM PLUS (K912736)Osbon Medical Systems, Ltd.1991-08-12
EER ERECTION ENHANCED RESPONDER (K904406)Eer, Inc.1991-02-25
FIRM MASTER (K905195)Bak Medical Products1991-02-01
SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE (K905015)Surgitek1990-12-28
SUPPORT PUMP (K904486)Numedtec, Inc.1990-12-14
SUPPORT RING (K904485)Numedtec, Inc.1990-12-14
VET (VACUUM ERECTION TECHNOLOGY) (K902240)Vetco, Inc.1990-10-12
VACUUM ERECTION DEVICE (VED) (K901223)Mission Pharmacal Co.1990-05-04
STAYEREC SYSTEM(TM) (K901318)Osbon Medical Systems, Ltd.1990-05-04
DACOMED NEGATIVE PRESSURE ERECTION DEVICE (K900774)Dacomed Corp.1990-05-04
RESPONSE EXTERNAL PENILE RIGIDITY DEVICE (K900559)Smith-Collins Pharmaceutical, Inc.1990-05-02
SAFE AID DEVICE IMPOTENCE DEVICE (K896357)Dr. John P. March1990-04-25
ERECTION INDUCER DEVICE (EID) (K896060)Performance Medical, Inc.1990-03-20
ERECTION DEVICE (K896061)Clyde Engineering Service1990-03-07
CONSTRICTOR RING FOR PENILE ERECTION (K891125)Performance, Inc.1989-04-27
THE BOOSTER (K860698)Knapps Corp.1989-02-03
MODIFIED L.J.'S SEX HELPER (K882531)L.J. Fant & Co.1988-12-08
MAXERECT (K881008)Kenneth Chapman1988-10-12
POS-T-VAC (K864833)Ekc, Inc.1987-04-10
IMPAX, MALE IMPOTENCE AID (K861468)Lehigh Group1986-06-18
REVIVE SYSTEM (K844445)Revive Systems Corp.1985-09-17
STA-POTENT SYSTEM (K841257)Nu-Potent1984-05-02
MALE THERAPEUTIC POTENT AID (K832543)Mace'S Scientific1983-12-27
PRI A PUS (K832756)Trans Texas Medical Devices Corp.1983-11-28

Track LKY automatically

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