FDA product code GXY: Electrode, Cutaneous
GXY is the FDA product code for electrode, cutaneous. It is a Class II device, regulated under 21 CFR 882.1320 and reviewed by the Neurology panel. FDA has cleared 440 510(k) submissions under GXY, 42 in the last five years, from 255 different applicants. The average 510(k) review took 127 days (median 90); 127 days on average over the last three years. FDA has posted 20 recalls for GXY devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Cutaneous |
| Device class | Class II |
| Regulation | 21 CFR 882.1320 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GXY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 147 |
| 2018 | 14 | 156 |
| 2019 | 9 | 135 |
| 2020 | 4 | 195 |
| 2021 | 12 | 230 |
| 2022 | 5 | 105 |
| 2023 | 13 | 167 |
| 2024 | 7 | 115 |
| 2025 | 6 | 153 |
| 2026 | 11 | 112 |
Compare with all 510(k) review times · Search every GXY clearance
Top GXY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Empi | 10 | 1990-06-08 |
| Medtronic Vascular | 10 | 1988-07-18 |
| Aspect Medical Systems, Inc. | 9 | 2009-10-23 |
| Labeltape Meditect, Inc. | 9 | 1992-01-14 |
| Axelgaard Mfg. Co., Ltd. | 8 | 2014-02-13 |
250 more applicants have GXY clearances. See the full list in Caduvo.
Most recent GXY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262654 | Zhejiang Qiangnao Technology Co.,Ltd | Dexus Prosthetic System (MSL2, MSR2) | 2026-08-27 | 28 |
| K260578 | Ambu A/S | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) | 2026-07-14 | 144 |
| K261442 | Cadwell Industries, Inc. | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | 2026-06-26 | 57 |
| K261522 | Biowave Corporation | BioWave BioWraps | 2026-06-03 | 27 |
| K253237 | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | 2026-05-08 | 221 |
Recalls for GXY devices
20 product recalls in 10 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-10-02.
| Year | Recalls |
|---|---|
| 2022 | 2 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code GXY?
GXY is the FDA product code for electrode, cutaneous. It is a Class II device, regulated under 21 CFR 882.1320 and reviewed by the Neurology panel.
What device class is GXY?
Class II, regulation 21 CFR 882.1320. Typical premarket route: 510(k).
How long does a 510(k) take for product code GXY?
Across 440 cleared submissions the average was 127 days from receipt to decision (median 90).
Which companies have the most GXY clearances?
Empi (10); Medtronic Vascular (10); Aspect Medical Systems, Inc. (9); Labeltape Meditect, Inc. (9); Axelgaard Mfg. Co., Ltd. (8).
Have GXY devices been recalled?
Yes: 20 product recalls across 10 recall events; the most recent began 2023-10-02.
Next steps
- Run an FDA pathway report with predicate devices for product code GXY
- Run a recall and safety report across every GXY manufacturer
- Watch product code GXY 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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