Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nidek, Inc. — Predicate Candidate Screening
77 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
210 days90th percentile
77clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050336 | OPD-STATION SOFTWARE | Nidek, Inc. | 2005-08-24 | 195 | 0 |
| K042785 | MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 | Nidek, Inc. | 2004-12-14 | 69 | 0 |
| K031733 | NON-CONTACT TONOMETER, MODEL NT-4000 | Nidek, Inc. | 2003-12-04 | 183 | 0 |
| K032085 | GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 | Nidek, Inc. | 2003-10-03 | 88 | 3 |
| K013694 | NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) | Nidek, Inc. | 2002-11-19 | 377 | 0 |
| K020876 | ECHOSCAN, MODEL US-1800 | Nidek, Inc. | 2002-05-03 | 46 | 0 |
| K014274 | NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 | Nidek, Inc. | 2002-04-17 | 111 | 0 |
| K013760 | DC-3300 LASER DIODE PHOTOCOAGULATOR | Nidek, Inc. | 2002-02-11 | 90 | 0 |
| K013864 | MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 | Nidek, Inc. | 2002-02-08 | 79 | 0 |
| K990119 | EPI-STAR SURGICAL LASER SYSTER | Nidek, Inc. | 2000-07-27 | 561 | 0 |
| K990900 | MICROKERATOME, MODEL MK-2000 | Nidek, Inc. | 1999-09-24 | 190 | 0 |
| K991284 | ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM | Nidek, Inc. | 1999-08-06 | 113 | 0 |
| K980475 | UNIPULSE CO2 SURGICAL LASER SYSTEM | Nidek, Inc. | 1998-12-16 | 313 | 0 |
| K982295 | NIDEK LIGHTSCAN | Nidek, Inc. | 1998-08-06 | 36 | 0 |
| K981447 | DIO-LIGHT 60 LASER SYSTEM | Nidek, Inc. | 1998-06-05 | 44 | 0 |
| K980547 | NIDEK PRIMA MODEL GYC-1500/2000 | Nidek, Inc. | 1998-05-13 | 90 | 0 |
| K974732 | NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000 | Nidek, Inc. | 1998-03-18 | 90 | 0 |
| K980201 | DIO-LIGHT LASER SYSTEM | Nidek, Inc. | 1998-03-16 | 55 | 0 |
| K973828 | PRIMA KTP LASER SYSTEM | Nidek, Inc. | 1998-01-05 | 90 | 0 |
| K973533 | NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3- | Nidek, Inc. | 1997-11-04 | 47 | 0 |
| K973218 | NIDEK HANDY | Nidek, Inc. | 1997-11-04 | 69 | 0 |
| K970017 | NIDEK CYBERSCAN | Nidek, Inc. | 1997-03-18 | 75 | 0 |
| K964353 | CYBERLASE CO2 LASER SYSTEM | Nidek, Inc. | 1997-02-28 | 119 | 0 |
| K960287 | HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM | Nidek, Inc. | 1996-11-05 | 288 | 0 |
| K951079 | NIDEK MODEL GYC-1500 AND GYC-2000 | Nidek, Inc. | 1995-09-14 | 189 | 0 |
| K951824 | STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) | Nidek, Inc. | 1995-07-19 | 90 | 0 |
| K936302 | NIDEK MODEL VT-4000, MODIFICATION | Nidek, Inc. | 1994-07-15 | 198 | 0 |
| K932836 | NIDEK MODEL AC-2300 | Nidek, Inc. | 1993-11-22 | 164 | 0 |
| K924353 | NIDEK MODEL VST-4000 | Nidek, Inc. | 1993-03-29 | 213 | 0 |
| K924260 | NIDEK CV-12000 | Nidek, Inc. | 1993-03-26 | 214 | 0 |
| K912384 | DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE | Nidek, Inc. | 1991-12-24 | 210 | 0 |
| K913465 | NIDEK MODELS AC-2100 & 2200 | Nidek, Inc. | 1991-10-21 | 77 | 0 |
| K913189 | NIDEK MODEL NT-1000 | Nidek, Inc. | 1991-10-15 | 89 | 0 |
| K903639 | NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR | Nidek, Inc. | 1991-02-04 | 175 | 0 |
| K904402 | NIDEK INC. MODEL AC-2000 DERM | Nidek, Inc. | 1990-12-07 | 73 | 0 |
| K903326 | NIDEK US-2000 | Nidek, Inc. | 1990-11-21 | 119 | 0 |
| K902411 | NIDEK US-2500 W/BIOMETRY UNIT US-2520 | Nidek, Inc. | 1990-10-09 | 131 | 0 |
| K900890 | NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA | Nidek, Inc. | 1990-09-10 | 195 | 0 |
| K900925 | NIDEK, INC. MODEL ADC-8000 DERM | Nidek, Inc. | 1990-09-10 | 195 | 0 |
| K902500 | AR-1600G AUTO-REFRACTOMETER | Nidek, Inc. | 1990-07-27 | 52 | 0 |
| K901481 | MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER | Nidek, Inc. | 1990-06-20 | 83 | 0 |
| K901513 | NIDEK RT-1200S (MARCO TRS-1200) | Nidek, Inc. | 1990-06-08 | 70 | 0 |
| K901686 | NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000 | Nidek, Inc. | 1990-06-08 | 57 | 0 |
| K900166 | NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS | Nidek, Inc. | 1990-03-27 | 74 | 0 |
| K900165 | NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM | Nidek, Inc. | 1990-03-22 | 69 | 0 |
| K895196 | MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR | Nidek, Inc. | 1989-10-16 | 66 | 0 |
| K894709 | NIDEK MODEL ADC-8000 | Nidek, Inc. | 1989-10-04 | 72 | 0 |
| K893987 | NIDEK MODEL YC-1200 | Nidek, Inc. | 1989-08-18 | 74 | 1 |
| K894273 | NIDEK MODEL AKC-8000 | Nidek, Inc. | 1989-08-07 | 46 | 0 |
| K892204 | NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS | Nidek, Inc. | 1989-06-22 | 80 | 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