Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nidek Co., Ltd. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
209 daysmedian FDA review time
286 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with I | Nidek Co., Ltd. | 2023-03-30 | 328 | 0 |
| K203130 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2020-12-07 | 49 | 0 |
| K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2019-11-15 | 107 | 0 |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | Nidek Co., Ltd. | 2019-04-01 | 56 | 0 |
| K181345 | Image Filing Software NAVIS-EX | Nidek Co., Ltd. | 2018-07-19 | 59 | 0 |
| K173980 | Specular Microscope CEM-530 | Nidek Co., Ltd. | 2018-03-14 | 75 | 0 |
| K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | Nidek Co., Ltd. | 2017-06-23 | 143 | 0 |
| K163564 | SLIT LAMP SL-2000 | Nidek Co., Ltd. | 2017-05-19 | 151 | 0 |
| K152729 | MICROPERIMETER MP-3 | Nidek Co., Ltd. | 2016-06-06 | 258 | 0 |
| K152603 | Green Laser Photocoagulator GYC-500 | Nidek Co., Ltd. | 2016-05-02 | 234 | 0 |
| K151706 | Specular Microscope CEM- 530 | Nidek Co., Ltd. | 2016-03-17 | 267 | 1 |
| K133358 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECT | Nidek Co., Ltd. | 2014-08-12 | 285 | 2 |
| K133132 | OPTICAL BIOMETER AL-SCAN | Nidek Co., Ltd. | 2014-06-11 | 254 | 0 |
| K132323 | RS-3000 ADVANCE | Nidek Co., Ltd. | 2014-02-19 | 209 | 0 |
| K130565 | SPECULAR MICROSCOPE CEM-530 | Nidek Co., Ltd. | 2013-11-27 | 268 | 0 |
| K131894 | NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WI | Nidek Co., Ltd. | 2013-10-31 | 128 | 0 |
| K121622 | NIDEK RS-3000 | Nidek Co., Ltd. | 2013-03-14 | 286 | 0 |
| K111493 | NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI | Nidek Co., Ltd. | 2011-07-27 | 57 | 0 |
| K072259 | OPHTHALMOSCOPE F-10 | Nidek Co., Ltd. | 2008-05-06 | 266 | 0 |
| K003299 | OPD-SCAN, MODELS ARK-10000 AND ARK-9000 | Nidek Co., Ltd. | 2001-03-09 | 140 | 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