Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LKY — Predicate Candidate Screening
87 FDA 510(k) clearances under this product code; the 50 most recent screened below.
100 daysmedian FDA review time
225 days90th percentile
87clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041573 | NANMA VACUUM PUMP PROXZEK MODEL 2M9498S | Nanma Mfg Co., Ltd. | 2004-08-25 | 72 | 0 |
| K032776 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | 2003-10-03 | 25 | 0 |
| K030119 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2003-08-06 | 205 | 0 |
| K030913 | NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | 2003-06-03 | 71 | 0 |
| K013113 | MODIFICATION TO NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | 2002-12-20 | 458 | 0 |
| K013051 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2002-08-22 | 345 | 0 |
| K020969 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | 2002-06-05 | 71 | 0 |
| K013053 | MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2002-05-09 | 240 | 0 |
| K020154 | VT-1 | Pos-T-Vac, Inc. | 2002-04-04 | 77 | 0 |
| K020258 | SUPPORT SLEEVE | Pos-T-Vac, Inc. | 2002-04-04 | 69 | 0 |
| K020082 | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAI | Endocare, Inc. | 2002-02-05 | 26 | 0 |
| K012662 | SE-100 VACUUM ERECTION DEVICE | Vts, Inc. | 2001-11-09 | 88 | 0 |
| K012670 | BOSS 2000-3 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | 2001-11-09 | 88 | 0 |
| K012619 | VT-1 | Vts, Inc. | 2001-11-09 | 88 | 0 |
| K012672 | BOSS-2000-2 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | 2001-11-09 | 88 | 0 |
| K012639 | SE-300 VACUUM THERAPY SYSTEM | Vts, Inc. | 2001-11-09 | 88 | 0 |
| K012620 | SE-200 | Vts, Inc. | 2001-11-09 | 88 | 0 |
| K001859 | PENILE CONSTRICTOR RING | Basic Solutions, LLC | 2001-01-11 | 206 | 0 |
| K003115 | ACTIS ADJUSTABLE CONSTRICTION LOOP | Vivus, Inc. | 2000-12-19 | 78 | 0 |
| K000730 | IMPOAID | Impoaid, Inc. | 2000-10-19 | 227 | 0 |
| K993909 | NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | 2000-07-19 | 245 | 0 |
| K000124 | SENSATION -VACUUM ASSIST DEVICES | Prosurg, Inc. | 2000-07-10 | 174 | 0 |
| K993343 | ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE B | Erecxel Enterprises | 2000-03-20 | 167 | 0 |
| K993906 | NANMA NON-ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2000-01-31 | 75 | 0 |
| K993908 | NANMA AJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2000-01-31 | 75 | 0 |
| K993142 | ELITE CUSTOM | Soma Blue, Inc. | 1999-12-27 | 97 | 0 |
| K993143 | VITALITY SYSTEM | Soma Blue, Inc. | 1999-12-27 | 97 | 0 |
| K992442 | V.T.S., INC. (V.T.-3) | Vts, Inc. | 1999-10-05 | 75 | 0 |
| K990008 | ERCO-RIBBON -C | Ercons, Inc. | 1999-02-24 | 51 | 0 |
| K990006 | ERCO-VAC -C | Ercons, Inc. | 1999-02-24 | 51 | 0 |
| K983438 | MAX IT | Dorea, Inc. | 1999-02-08 | 132 | 0 |
| K982275 | RAPPORT V.T.D. | Owen Mumford USA, Inc. | 1998-12-04 | 158 | 0 |
| K981343 | ERCO-RIBBON | Ercons, Inc. | 1998-11-24 | 225 | 0 |
| K981357 | ERCO-VAC | Ercons, Inc. | 1998-11-24 | 224 | 0 |
| K983245 | POS-T-VAC (AVP-1000) | Pos-T-Vac, Inc. | 1998-11-02 | 47 | 0 |
| K983246 | POS-T-VAC (IVP-600) | Pos-T-Vac, Inc. | 1998-11-02 | 47 | 0 |
| K981011 | POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) | Pos-T-Vac, Inc. | 1998-08-28 | 163 | 0 |
| K981180 | REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS- | Pos-T-Vac, Inc. | 1998-08-28 | 149 | 0 |
| K980948 | VED VALU- VACUUM ERECTION DEVICE | Mission Pharmacal Comp | 1998-06-25 | 104 | 0 |
| K981506 | RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVI | Repro-Med Systems, Inc. | 1998-06-25 | 59 | 0 |
| K974196 | MEGAVAC SYSTEM | Barry J. Kaplan, Inc. | 1998-05-12 | 186 | 0 |
| K980752 | XTEND | Walling Medical Equipment Co. | 1998-05-06 | 75 | 0 |
| K980567 | CHARGER (ED) | Walling Medical Equipment Co. | 1998-05-06 | 82 | 0 |
| K980291 | IMPOWER EXTERNAL VACUUM SYSTEM | Imagyn Medical Technologies, Inc. | 1998-03-11 | 44 | 0 |
| K974082 | THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS | Performance Plus, Inc. | 1998-02-27 | 121 | 0 |
| K974173 | ERECAID SYSTEM/STAY EREC SYSTEM | Imagyn Medical Technologies, Inc. | 1998-02-25 | 112 | 0 |
| K974215 | VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET | Vetco, Inc. | 1998-02-19 | 101 | 0 |
| K974470 | VTU-E VACUUM ERECTION SYSTEM | Encore, Inc. | 1998-01-09 | 44 | 0 |
| K972537 | ERCO-VAC | Ercons, Inc. | 1997-11-03 | 118 | 0 |
| K972353 | ERCO-RIBBON | Ercons, Inc. | 1997-10-28 | 126 | 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