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FDA product code · Neurology · Class 2

GXY: Electrode, Cutaneous

GXY is FDA's product code for "Electrode, Cutaneous": a Class 2 device classified under 21 CFR 882.1320, reviewed by the Neurology panel.

510(k) review time for GXY

Across 81 510(k) clearances under GXY decided from 2018-01-01 to 2026-10-06, the median was 132 days from FDA receipt to decision. Half took between 62 and 210 days, and 80% were decided within 231 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, GXY, decisions 2018-01-01 to 2026-10-06 (n = 81)
Fastest11
25th percentile62
Median132
75th percentile210
80th percentile231
90th percentile296
Slowest602
Median days by decision year, GXY (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
201813514
20191139
202119512
2022815
202313213
20241117
20251486
2026 (to 10-06, partial)5811

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.

GXY in the public FDA record

Records naming GXY, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years440
Device recalls20
Establishment listings490
GUDID device identifiers5,502

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

3 FDA recognized consensus standards cite GXY, 1 of them recognized only in part, among them IEEE Std 2010-2023; IEC 60601-2-40 Third edition 2024-12; ANSI AAMI EC12:2000/(R)2015. 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
  • 17-20 IEC 60601-2-40 Third edition 2024-12 — Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
  • 3-52 ANSI AAMI EC12:2000/(R)2015 (partial recognition) — Disposable ECG electrodes

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

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