FDA product code · Neurology · Class 2
GWN: Nystagmograph
GWN is FDA's product code for "Nystagmograph": a Class 2 device classified under 21 CFR 882.1460, reviewed by the Neurology panel.
510(k) review time for GWN
Across 11 510(k) clearances under GWN decided from 2018-01-01 to 2026-10-06, the median was 115 days from FDA receipt to decision. Half took between 92 and 183 days, and 80% were decided within 203 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 92 |
| Median | 115 |
| 75th percentile | 183 |
| 80th percentile | 203 |
| 90th percentile | 266 |
| Slowest | 273 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
GWN in the public FDA record
| 510(k) clearances, all years | 60 |
|---|
Counts of records, not of devices or events. Adverse event reports for GWN are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite GWN
1 FDA recognized consensus standard cite GWN, among them ANSI ASA S3.45-2009 (Reaffirmed 2024). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-185 ANSI ASA S3.45-2009 (Reaffirmed 2024) — American National Standard Procedures for Testing Basic Vestibular Function
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.