Nidek, Inc.: FDA filings under this applicant name
FDA lists 97 510(k) clearances under the applicant name “Nidek, Inc.” (first 1983, latest 2023), plus 2 PMA decisions, across 25 product codes in 4 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 91 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 268 |
| 2014 | 3 | 254 |
| 2015 | 0 | — |
| 2016 | 3 | 258 |
| 2017 | 2 | 147 |
| 2018 | 2 | 67 |
| 2019 | 2 | 82 |
| 2020 | 1 | 49 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 328 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nidek, Inc. took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 23 | 23 |
| HQF | Laser, Ophthalmic | 13 | 13 |
| HKO | Refractometer, Ophthalmic | 8 | 8 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 7 | 7 |
| HKI | Camera, Ophthalmic, Ac-Powered | 5 | 5 |
| HLQ | Keratoscope, Ac-Powered | 4 | 4 |
| HQB | Photocoagulator And Accessories | 4 | 4 |
| HQC | Unit, Phacofragmentation | 4 | 4 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 4 | 4 |
| HLI | Ophthalmoscope, Ac-Powered | 3 | 3 |
Plus 15 more product codes.
Review panels
- Ophthalmic (68)
- General and Plastic Surgery (23)
- Radiology (7)
- Anesthesiology (1)
Most recent Nidek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX | OBO | 2023-03-30 | 328 |
| K203130 | Ophthalmic Yag Laser System YC-200 | HQF | 2020-12-07 | 49 |
| K192045 | Ophthalmic Yag Laser System YC-200 | HQF | 2019-11-15 | 107 |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | HKI | 2019-04-01 | 56 |
| K181345 | Image Filing Software NAVIS-EX | NFJ | 2018-07-19 | 59 |
| K173980 | Specular Microscope CEM-530 | NQE | 2018-03-14 | 75 |
| K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | HQF | 2017-06-23 | 143 |
| K163564 | SLIT LAMP SL-2000 | HJO | 2017-05-19 | 151 |
| K152729 | MICROPERIMETER MP-3 | HKI | 2016-06-06 | 258 |
| K152603 | Green Laser Photocoagulator GYC-500 | HQF | 2016-05-02 | 234 |
87 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P970053 | PMA | EC-5000 EXCIMER LASER SYSTEM | 1998-12-17 |
| P830062 | PMA | ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 | 1984-09-27 |
Recalls
21 product recalls in 20 recall events; 0 initiated in the last five years. Most recent: 2019-02-25.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Nidek, Inc. is the lead sponsor of 11 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06363045: Comparative Study of the NIDEK TONOREF III with Predicate Devices (Completed, started 2024-06-27)
- NCT07152808: Clinical Study for TONOREF III Tested to ANSI Z80.10-2014 (Completed, started 2022-09-02)
- NCT04318132: Agreement and Precision Study of the Nidek Mirante (Completed, started 2020-01-25)
- NCT03441477: Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530 (Completed, started 2017-12-17)
- NCT03247751: Evaluation of the Rotational Stability (Completed, started 2016-06)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Nidek, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nidek Medical Products, Inc. (12 510(k)s)
- Nidek Technologies Srl (5 510(k)s)
- Nidek Incorporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nidek, Inc.?
FDA lists 97 510(k) clearances under the applicant name “Nidek, Inc.” (first 1983, latest 2023), plus 2 PMA decisions, across 25 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nidek, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nidek, Inc. is 88 days. Since 2017: 91 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nidek, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 23); HQF (Laser, Ophthalmic, 13); HKO (Refractometer, Ophthalmic, 8).
Next steps
- See all 97 Nidek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Nidek, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.