FDA product code · Neurology · Class 2
GWM: Device, Monitoring, Intracranial Pressure
GWM is FDA's product code for "Device, Monitoring, Intracranial Pressure": a Class 2 device classified under 21 CFR 882.1620, reviewed by the Neurology panel.
510(k) review time for GWM
Across 12 510(k) clearances under GWM decided from 2018-01-01 to 2026-10-06, the median was 127 days from FDA receipt to decision. Half took between 30 and 275 days, and 80% were decided within 292 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 30 |
| Median | 127 |
| 75th percentile | 275 |
| 80th percentile | 292 |
| 90th percentile | 428 |
| Slowest | 448 |
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.
GWM in the public FDA record
| 510(k) clearances, all years | 105 |
|---|---|
| Device recalls | 52 |
| Establishment listings | 208 |
| GUDID device identifiers | 653 |
Counts of records, not of devices or events. Adverse event reports for GWM 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 GWM
3 FDA recognized consensus standards cite GWM, 1 of them recognized only in part, among them AAMI NS28:1988/(R) 2015; ISO 80369-6 First Edition 2016-03-15; ISO 80369-6 Second edition 2025-05. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 17-1 AAMI NS28:1988/(R) 2015 (partial recognition) — Intracranial pressure monitoring devices
- 5-108 ISO 80369-6 First Edition 2016-03-15 — Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
- 5-146 ISO 80369-6 Second edition 2025-05 — Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.