FDA product code · Neurology
GXYElectrode, Cutaneous
Product code GXY covers Electrode, Cutaneous, a Class II device regulated under 21 CFR 882.1320. FDA has cleared 439 devices in this code, 12 of them in the last 12 months. Median review time across the 439 most recent decisions is 90 days. openFDA lists 20 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 882.1320
- Review panel
- Neurology
- Clearances
- 439
What is happening in GXY right now?
GXY (Electrode, Cutaneous) has three findings, most consequential first. 5 first-time filers in the last 12 months, including Ambu A/S and Cadwell Industries Inc (K260578, K261442, K253237, K252439, K250841). Clearances are running 50% slower — a median 135 days over the last 12 months against 90 days all-time (elapsed calendar days, not FDA review days) (GXY:review_time:12m). The code is crowded, scoring 97 of 100 — 251 companies hold a clearance here and 12 arrived in the last 12 months (GXY:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K260578, K261442, K253237, K252439, K250841 |
| Review time | Context | GXY:review_time:12m |
| Crowding | Context | GXY:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in GXY?
FDA has cleared 439 devices under product code GXY since the 510(k) programme began in 1976, 12 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260578 | 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) | Ambu A/S | |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. | |
| K261522 | BioWave BioWraps | Biowave Corporation | |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | |
| K254183 | MR Conditional Cup Electrodes | Technomed Europe | |
| K252439 | Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. | |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | |
| K260363 | Ceribell Brain Monitor Headband | Ceribell, Inc. | |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | |
| K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. |
How long does FDA review take for GXY?
The median FDA review time for GXY is 90 days, measured across the 439 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in GXY?
openFDA lists 20 recall records against product code GXY. A recall record covers one firm's corrective action and may span many device lots.
Z-0203-2024Open, ClassifiedCoapt LLC
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Z-0204-2024Open, ClassifiedCoapt LLC
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Z-1595-2022Open, ClassifiedMckesson Medical-Surgical Inc. Corporate Office
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1091-2022Open, ClassifiedNeuralynx, Inc.
Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.
Z-1583-2014TerminatedMedtronic Navigation, Inc.
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
Showing the 5 most recently initiated of 20. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for GXY?
MAUDE holds 145 adverse-event reports naming product code GXY, 46 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in GXY unusual?
Every month with enough history behind it falls inside GXY's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 5 | 1–8 | Within expected (1–8) | |
| 3 | 1–7 | Within expected (1–7) | |
| 7 | 1–7 | Within expected (1–7) | |
| 6 | 2–9 | Within expected (2–9) | |
| 2 | 2–9 | Within expected (2–9) | |
| 4 | 0–8 | Within expected (0–8) | |
| 3 | 1–12 | Within expected (1–12) | |
| 2 | 0–8 | Within expected (0–8) | |
| 8 | 0–8 | Within expected (0–8) | |
| 9 | 0–10 | Within expected (0–10) | |
| 5 | 1–10 | Within expected (1–10) | |
| 3 | 1–11 | Within expected (1–11) | |
| 6 | 0–12 | Within expected (0–12) | |
| 3 | 0–10 | Within expected (0–10) | |
| 10 | 0–10 | Within expected (0–10) |
20 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in GXY.
Who has entered GXY in the last year?
5 companies filed in GXY for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Ambu A/S | K260578 | |
| Cadwell Industries Inc | K261442 | |
| Elde Medikal Sanayi ve Ticaret Anonim Sirketi | K253237 | |
| Dongguan Tutamen Metalwork Co., Ltd. | K252439 | |
| Baisheng Medical Co., Ltd. | K250841 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in GXY?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in GXY?
Across the 439 most recent decisions, these applicants filed most often in GXY.
| Applicant | Recent clearances |
|---|---|
| Empi | 10 |
| Medtronic Vascular | 10 |
| Aspect Medical Systems, Inc. | 9 |
| Labeltape Meditect, Inc. | 9 |
| Axelgaard Mfg. Co., Ltd. | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch GXY
Get an email the morning anything changes in GXY — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.