GWQ: Full-Montage Standard Electroencephalograph

510(k) review time for GWQ

Across 26 510(k) clearances under GWQ decided from 2018-01-01 to 2026-10-06, the median was 168 days from FDA receipt to decision. Half took between 90 and 265 days, and 80% were decided within 280 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, GWQ, decisions 2018-01-01 to 2026-10-06 (n = 26)

Fastest	30
25th percentile	90
Median	168
75th percentile	265
80th percentile	280
90th percentile	310
Slowest	422

Median days by decision year, GWQ (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.

Year	Median days	n
2018	150	8
2020	216	6
2023	137	6

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.

GWQ in the public FDA record

Records naming GWQ, from openFDA (snapshot of 2026-09-15)

510(k) clearances, all years	189
Device recalls	23
Establishment listings	279
GUDID device identifiers	828

Counts of records, not of devices or events. Adverse event reports for GWQ 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 GWQ

2 FDA recognized consensus standards cite GWQ, 1 of them recognized only in part, among them IEEE Std 2010-2023; IEC 80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

• 17-18 IEEE Std 2010-2023 — Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems
• 17-23 IEC 80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION (partial recognition) — Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

Related product codes

• OLT Non-Normalizing Quantitative Electroencephalograph Software
• OLV Standard Polysomnograph With Electroencephalograph
• OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
• OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
• OMC Reduced- Montage Standard Electroencephalograph
• NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter