FDA product code GWN: Nystagmograph
GWN is the FDA product code for nystagmograph. It is a Class II device, regulated under 21 CFR 882.1460 and reviewed by the Neurology panel. FDA has cleared 60 510(k) submissions under GWN, 5 in the last five years, from 44 different applicants. The average 510(k) review took 151 days (median 112); 178 days on average over the last three years. FDA has posted 4 recalls for GWN devices.
Classification
| Field | Value |
|---|---|
| Device name | Nystagmograph |
| Device class | Class II |
| Regulation | 21 CFR 882.1460 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GWN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 180 |
| 2018 | 3 | 71 |
| 2019 | 1 | 109 |
| 2020 | 2 | 96 |
| 2023 | 1 | 273 |
| 2025 | 3 | 195 |
| 2026 | 1 | 161 |
Compare with all 510(k) review times · Search every GWN clearance
Top GWN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Interacoustics A/S | 5 | 2020-08-12 |
| Neuro Kinetics, Inc. | 3 | 2018-07-24 |
| Micromedical Technologies, Inc. | 3 | 1997-07-15 |
| Philadelphia Medical Specialties | 3 | 1984-02-10 |
| Gn Otometrics | 2 | 2015-11-16 |
39 more applicants have GWN clearances. See the full list in Caduvo.
Most recent GWN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260566 | VertigoDx, Inc. | SMARTVERTIGO Vestibular Assessment System | 2026-07-30 | 161 |
| K243709 | Neuroears, Inc. | NeuroEars-Anna | 2025-08-25 | 266 |
| K242198 | Natus Medical Denmark Aps | ICS Dizcovery (1091) | 2025-02-14 | 203 |
| K242726 | Inventis S.R.L. | Synapsys VHIT | 2025-01-03 | 115 |
| K223047 | Neurobit Technologies Co., Ltd. | NeuroSwift Pro | 2023-06-29 | 273 |
Recalls for GWN devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-07-21.
Frequently asked questions
What is FDA product code GWN?
GWN is the FDA product code for nystagmograph. It is a Class II device, regulated under 21 CFR 882.1460 and reviewed by the Neurology panel.
What device class is GWN?
Class II, regulation 21 CFR 882.1460. Typical premarket route: 510(k).
How long does a 510(k) take for product code GWN?
Across 60 cleared submissions the average was 151 days from receipt to decision (median 112).
Which companies have the most GWN clearances?
Interacoustics A/S (5); Neuro Kinetics, Inc. (3); Micromedical Technologies, Inc. (3); Philadelphia Medical Specialties (3); Gn Otometrics (2).
Have GWN devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2015-07-21.
Next steps
- Run an FDA pathway report with predicate devices for product code GWN
- Run a recall and safety report across every GWN manufacturer
- Watch product code GWN 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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