Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OKS — Predicate Candidate Screening
31 FDA 510(k) clearances under this product code; the 50 most recent screened below.
166 daysmedian FDA review time
300 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201892 | Ritleng®+ and Ritleng®+ PVP | Fci (France Chirurgie Instrumentation) Sas | 2021-03-11 | 246 | 0 |
| K201606 | LacriJet® | Fci (France Chirurgie Instrumentation) Sas | 2020-12-18 | 186 | 0 |
| K170247 | Lacriflow CL | Kaneka Pharma America, LLC | 2017-04-18 | 81 | 0 |
| K161373 | Nunchaku | Fci (France Chirurgie Instrumentation) | 2016-11-03 | 170 | 0 |
| K160710 | Oasis Lacrimal Intubation Set | Anodyne | 2016-05-13 | 59 | 0 |
| K142914 | DacryoCATH | Armadillo Biomedical, LLC | 2015-01-12 | 97 | 0 |
| K140290 | STOPLOSS JONES TUBE | Ljt Surgical, Ltd. | 2014-12-02 | 300 | 0 |
| K130375 | SELF-RETAINING BICANALICULUS INTUBATON SET II | Fci Sas (France Chirurgie Instrumentation) | 2013-12-04 | 293 | 0 |
| K123831 | OPHTACATH KIT | France Chirurgae Instrumentation | 2013-07-29 | 229 | 0 |
| K120886 | LACRIFAST | Hiroyasu Higuchi | 2012-12-17 | 269 | 0 |
| K113316 | DCS LACRIMAL STENT | Dcs Surgical, Inc. | 2012-11-08 | 365 | 0 |
| K113867 | LACRICATH LACRIMAL DUCT CATHETER | Quest Medical, Inc. | 2012-10-19 | 294 | 0 |
| K113508 | DACRYOCATH | Armadillo Biomedical, LLC | 2012-08-31 | 277 | 0 |
| K121142 | CRAWFORD BIOCANALICULUS INTUBATION | Fci Sas (France Chirurgie Instrumentation) | 2012-08-09 | 115 | 0 |
| K113536 | MASTERKA 40 MASTERKA 35 MASTERKA 30 | Fci Sas (France Chirurgie Instrumentation) | 2012-08-03 | 247 | 0 |
| K113118 | STENTUBE LACRIMAL INTUBATION SET | Quest Medical, Inc. | 2012-07-31 | 284 | 0 |
| K061404 | MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE | Fci Ophthalmics, Inc. | 2006-08-07 | 80 | 0 |
| K041869 | SELF RETAINING BICANALICULUS INTUBATION SET | Fci Ophthalmics, Inc. | 2004-11-18 | 132 | 0 |
| K023758 | BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) | Fci Ophthalmics, Inc. | 2003-09-17 | 313 | 0 |
| K030353 | MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS | Eagle Vision, Inc. | 2003-04-25 | 81 | 0 |
| K012108 | MEDPOR COATED TEAR DRAIN | Porex Surgical, Inc. | 2001-12-19 | 166 | 0 |
| K991238 | FCI CRAWFORD PROBE INTUBATION SETS | Fci Ophthalmics, Inc. | 1999-07-08 | 87 | 0 |
| K990672 | LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET | Hurricane Medical | 1999-05-18 | 77 | 0 |
| K973633 | ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET | Atrion Medical Products, Inc. | 1998-01-16 | 183 | 0 |
| K973872 | ATRION MEDICAL COATED LACRIMAL INTUBATION SET | Atrion Medical Products, Inc. | 1998-01-08 | 90 | 0 |
| K962151 | RYDER LACRIMAL INTUBATIONSET | Ryder Intl. Corp. | 1996-09-18 | 106 | 0 |
| K955671 | RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) | G.W.B. Intl., Ltd. | 1996-03-06 | 93 | 0 |
| K935233 | IOLAB LACRIMAL DUCT CATHETER | Chiron Vision Corp. | 1994-09-15 | 318 | 0 |
| K940508 | OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) | G.W.B. Intl., Ltd. | 1994-05-04 | 89 | 0 |
| K911109 | OPHTA SIL (R), LACHRYMAL INTUBATION SETS | G.W.B. Intl., Ltd. | 1991-05-01 | 58 | 0 |
| K883233 | EV MONOCANALICULAR STENT (TM) | Eagle Vision, Inc. | 1988-08-22 | 21 | 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