FDA product code NQE: Microscope, Specular
NQE is the FDA product code for microscope, specular. It is a Class II device, regulated under 21 CFR 886.1850 and reviewed by the Ophthalmic panel. FDA has cleared 9 510(k) submissions under NQE, from 4 different applicants. The average 510(k) review took 229 days (median 267). FDA has posted 2 recalls for NQE devices.
Definition
Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
Classification
| Field | Value |
|---|---|
| Device name | Microscope, Specular |
| Device class | Class II |
| Regulation | 21 CFR 886.1850 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NQE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 168 |
| 2020 | 1 | 288 |
Compare with all 510(k) review times · Search every NQE clearance
Top NQE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Konan Medical, Inc. | 4 | 2020-03-26 |
| Nidek Co., Ltd. | 3 | 2018-03-14 |
| Tomey Corporation | 1 | 2018-01-19 |
| Topcon Corporation | 1 | 2015-05-29 |
Most recent NQE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191558 | Konan Medical, Inc. | Konan Specular Microscope XVII | 2020-03-26 | 288 |
| K173980 | Nidek Co., Ltd. | Specular Microscope CEM-530 | 2018-03-14 | 75 |
| K171313 | Tomey Corporation | EM-4000 Specular Microscope | 2018-01-19 | 260 |
| K151706 | Nidek Co., Ltd. | Specular Microscope CEM- 530 | 2016-03-17 | 267 |
| K142417 | Topcon Corporation | SP-1PSpecular Microscope | 2015-05-29 | 274 |
Recalls for NQE devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-02-25.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code NQE?
NQE is the FDA product code for microscope, specular. It is a Class II device, regulated under 21 CFR 886.1850 and reviewed by the Ophthalmic panel.
What device class is NQE?
Class II, regulation 21 CFR 886.1850. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQE?
Across 9 cleared submissions the average was 229 days from receipt to decision (median 267).
Which companies have the most NQE clearances?
Konan Medical, Inc. (4); Nidek Co., Ltd. (3); Tomey Corporation (1); Topcon Corporation (1).
Have NQE devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2019-02-25.
Next steps
- Run an FDA pathway report with predicate devices for product code NQE
- Run a recall and safety report across every NQE manufacturer
- Watch product code NQE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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