Medical device manufacturer
Nidek, Inc.
Nidek, Inc. holds 98 FDA 510(k) clearances across 23 product codes. Median elapsed review time is 87 days. openFDA lists 21 recall records naming the company. FDA publishes it under 11 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 98
- Product codes
- 23
- Median review
- 87 days
- Recall records
- 21
How does FDA spell Nidek, Inc.?
FDA publishes this company under 11 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| NIDEK CO., LTD. | device/registrationlisting | normalised |
| NIDEK INCORPORATED | device/registrationlisting | normalised |
| Nidek Co., Ltd. | device/510k | normalised |
| Nidek Inc | device/enforcement | normalised |
| Nidek Inc | device/recall | normalised |
| Nidek Inc. | device/enforcement | normalised |
| Nidek Inc. | device/recall | normalised |
| Nidek Incorporated | device/510k | normalised |
Showing 8 of 11.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Nidek, Inc. file in?
23 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 23 | 83 days | |
| HQF | Laser, Ophthalmic | 13 | 107 days | |
| HKO | Refractometer, Ophthalmic | 8 | 21 days | |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 7 | 88 days | |
| HKI | Camera, Ophthalmic, Ac-Powered | 5 | 69 days | |
| HQB | Photocoagulator And Accessories | 5 | 55 days | |
| HLQ | Keratoscope, Ac-Powered | 4 | 49 days | |
| HQC | Unit, Phacofragmentation | 4 | 90 days | |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 4 | 198 days | |
| HLI | Ophthalmoscope, Ac-Powered | 3 | 156 days | |
| NQE | Microscope, Specular | 3 | 267 days | |
| OBO | Tomography, Optical Coherence | 3 | 286 days | |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | 151 days | |
| HKX | Tonometer, Ac-Powered | 2 | 89 days | |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 2 | 26 days | |
| LXS | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla | 2 | 74 days | |
| NFJ | System, Image Management, Ophthalmic | 2 | 59 days | |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 356 days | |
| HNO | Keratome, Ac-Powered | 1 | 190 days | |
| HQL | Intraocular Lens | 1 | 74 days | |
| MXK | Device, Analysis, Anterior Segment | 1 | 113 days | |
| MYC | Ophthalmoscope, Laser, Scanning | 1 | 266 days | |
| NCF | Aberrometer, Ophthalmic | 1 | 195 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Nidek, Inc. had a recall?
openFDA lists 21 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0771-2020Class IIITerminatedNQE
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Z-0655-2019Class IIITerminatedHKN
The lens bonding was incomplete on the refractor.
Z-1348-2018Class IITerminatedHKO
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
Z-1494-2017Class IITerminatedLZS
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
Z-2711-2016Class IITerminatedNQE
Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.
Showing the 5 most recently initiated of 21.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Nidek, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed 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 | 328 | |
| K203130 | Ophthalmic Yag Laser System YC-200 | HQF | 49 | |
| K192045 | Ophthalmic Yag Laser System YC-200 | HQF | 107 | |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | HKI | 56 | |
| K181345 | Image Filing Software NAVIS-EX | NFJ | 59 | |
| K173980 | Specular Microscope CEM-530 | NQE | 75 | |
| K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | HQF | 143 | |
| K163564 | SLIT LAMP SL-2000 | HJO | 151 | |
| K152729 | MICROPERIMETER MP-3 | HKI | 258 | |
| K152603 | Green Laser Photocoagulator GYC-500 | HQF | 234 |
Source: openFDA device/510k · retrieved
Where is Nidek, Inc. registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Nidek, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.