Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LZU — Predicate Candidate Screening
49 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
223 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241229 | Hello,eyes® BIO Plug | Bio Optics Co., Ltd. | 2024-06-28 | 57 | 0 |
| K222164 | Visant Medical Canalicular Plug | Visant Medical, Inc. | 2022-12-23 | 155 | 0 |
| K213988 | SOFT PLUG Extended Duration 180 Tapered Canalicular Plug | Oasis Medical, Inc. | 2022-06-03 | 165 | 0 |
| K190210 | Tear Pool Dissolvable Punctum Plugs | Alphamed, Inc. | 2019-10-24 | 262 | 0 |
| K162361 | Soft Plug Extended Duration 180 Canalicular Plug | Oasis Medical, Inc. | 2017-04-17 | 237 | 0 |
| K161673 | LacriPro Punctum Plug | Lacrimedics, Inc. | 2016-11-18 | 155 | 0 |
| K150288 | PDO Absorbable Punctum Plug | Riverpoint Medical | 2015-08-28 | 204 | 0 |
| K140352 | VERAPLUG | Krishna Imports Inc Dba Stephens Instruments | 2014-11-13 | 274 | 0 |
| K140711 | COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE AB | Paragon Bioteck, Inc. | 2014-06-20 | 91 | 0 |
| K140026 | COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST | Lacrimedics, Inc. | 2014-06-03 | 148 | 1 |
| K090938 | FLOW CONTROLLER | Odyssey Medical, Inc. | 2009-06-04 | 62 | 0 |
| K061398 | SNUG PLUG PUNCTUM PLUG | Fci Ophthalmics, Inc. | 2006-07-11 | 53 | 0 |
| K053333 | EAGLEVISION GELLANSERTS, MODEL REF 0040 | Eagle Vision, Inc. | 2006-05-02 | 152 | 0 |
| K050851 | DELTA PUNCTUM PLUG | Delta Life Science, Inc. | 2005-08-19 | 137 | 0 |
| K040912 | HYDROGEL CANALICULAR PLUG | Partners IN Biomaterials, Inc. | 2004-11-16 | 222 | 0 |
| K040231 | INTELIPORT OCCLUDING DEVICE | Alcon, Inc. | 2004-07-13 | 162 | 0 |
| K030300 | OPAQUE HERRICK LACRIMAL PLUG | Lacrimedics, Inc. | 2003-05-09 | 100 | 0 |
| K022043 | SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH RO | Medennium, Inc. | 2002-10-18 | 116 | 0 |
| K021936 | MOIST PUNCTAL PLUG SYSTEM | Moist Medical, Inc. | 2002-10-16 | 126 | 0 |
| K020882 | SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG | Surgical Specialties Corp | 2002-07-26 | 130 | 0 |
| K021831 | OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3 | Lacrimedics, Inc. | 2002-07-01 | 27 | 0 |
| K013613 | SOFT PLUG ABSORBABLE PLUG-SA | Oasis Medical, Inc. | 2002-06-27 | 234 | 1 |
| K001768 | OCCU-FLO PUNCTUM PLUGS | U.S. Iol, Inc. | 2000-09-19 | 99 | 0 |
| K001234 | BIOINSULATED SILICONE PUNCTUM PLUG | Advanced Vision Science | 2000-07-11 | 85 | 0 |
| K001737 | OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM | Lacrimedics, Inc. | 2000-06-19 | 12 | 0 |
| K991130 | FLEXPLUG | Eagle Vision, Inc. | 1999-04-20 | 18 | 0 |
| K980844 | SURGIDEV SILICONE PUNCTUM PLUG | Advanced Vision Science | 1998-05-11 | 68 | 0 |
| K980437 | SILICONE PUNCTAL PLUG | Oasis Medical, Inc. | 1998-04-30 | 85 | 0 |
| K972523 | PUNCTUAL OCCLUDER | Odyssey Medical, Inc. | 1997-09-09 | 64 | 0 |
| K970631 | PUNCTUAL OCCLUDER | Odyssey Medical, Inc. | 1997-04-23 | 63 | 0 |
| K963708 | HERRICK ULTIMATE PUNCTUM PLUG | Lacrimedics, Inc. | 1997-04-14 | 210 | 0 |
| K963501 | HERRICK ULTIMATE PUNCTUM PLUG | Lacrimedics, Inc. | 1997-04-14 | 223 | 0 |
| K964774 | PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS | Fci Ophthalmics, Inc. | 1996-12-20 | 59 | 0 |
| K961909 | READY-SET PUNCTAL PLUGS | Fci Ophthalmics, Inc. | 1996-07-25 | 70 | 0 |
| K953394 | VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} | Visitec Co. | 1995-10-12 | 87 | 0 |
| K954094 | OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) | G.W.B. Intl., Ltd. | 1995-10-05 | 42 | 0 |
| K950569 | OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)} | G.W.B. Intl., Ltd. | 1995-03-14 | 41 | 0 |
| K946357 | COLLAGEN INTRACANALICULAR PLUG | Oasis Medical, Inc. | 1995-02-07 | 39 | 0 |
| K945906 | SILICONE PUNCTAL PLUG | Oasis Medical, Inc. | 1995-01-03 | 32 | 0 |
| K915809 | VISITEC CANALICULAR STENT | Visitec Co. | 1992-02-24 | 62 | 0 |
| K905427 | EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG | Eagle Vision, Inc. | 1991-06-06 | 184 | 0 |
| K911108 | OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS | G.W.B. Intl., Ltd. | 1991-05-13 | 70 | 0 |
| K905750 | LACRIMAL PLUG | Tamcenan Corp. | 1991-03-14 | 80 | 0 |
| K897190 | LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT | Look, Inc. | 1990-03-28 | 90 | 0 |
| K896175 | HERRICK LACRIMAL PLUG TM. | Lacrimedics, Inc. | 1990-01-22 | 89 | 0 |
| K895342 | COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST | Lacrimedics, Inc. | 1989-11-02 | 63 | 0 |
| K890714 | LACRIMAL EFFICIENCY TEST (TM) | Lacrimedics, Inc. | 1989-05-17 | 93 | 0 |
| K890919 | TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT | Eagle Vision, Inc. | 1989-05-16 | 82 | 0 |
| K890920 | EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE | Eagle Vision, Inc. | 1989-04-11 | 47 | 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