FDA product code · Cardiovascular
DRXElectrode, Electrocardiograph
Product code DRX covers Electrode, Electrocardiograph, a Class II device regulated under 21 CFR 870.2360. FDA has cleared 329 devices in this code. Median review time across the 329 most recent decisions is 86 days. openFDA lists 20 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.2360
- Review panel
- Cardiovascular
- Clearances
- 329
What is happening in DRX right now?
DRX (Electrode, Electrocardiograph): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in DRX?
FDA has cleared 329 devices under product code DRX since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171244 | Physiotrace | Nimbleheart, Inc. | |
| K140096 | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE | Hmicro, Inc. | |
| K123658 | BIOMODULE 3-M1 | Zephyr Technology Corporation | |
| K101576 | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES | Team Innovations, Inc. | |
| K101685 | IP-SET | Integral Process Sas | |
| K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | Ambu A/S | |
| K093327 | INTCO TAB ELECTRODE | Shanghai Intco Electrode Manufacturing Co., Ltd. | |
| K100315 | 12 LEAD GLOVE | I Needmd, Inc. | |
| K092744 | NEONATAL ECG ELECTRODE, M203KEN | R & D Medical Products, Inc. | |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | Suzuken Co., Ltd. |
How long does FDA review take for DRX?
The median FDA review time for DRX is 86 days, measured across the 329 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 DRX?
openFDA lists 20 recall records against product code DRX. A recall record covers one firm's corrective action and may span many device lots.
Z-0935-2022TerminatedGraphic Controls Acquisition Corporation
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
Z-0936-2022TerminatedGraphic Controls Acquisition Corporation
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
Z-0937-2022TerminatedGraphic Controls Acquisition Corporation
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
Z-0938-2022TerminatedGraphic Controls Acquisition Corporation
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
Z-0939-2022TerminatedGraphic Controls Acquisition Corporation
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
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 DRX?
MAUDE holds 503 adverse-event reports naming product code DRX, 247 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 DRX unusual?
4 months sit above DRX's own expected range: 1 April 2025, 1 June 2025, 1 July 2025, 1 September 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 7 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | 0–11 | Within expected (0–11) | |
| 6 | 0–10 | Within expected (0–10) | |
| 7 | 0–10 | Within expected (0–10) | |
| 12 | 0–11 | Above expected (0–11) | |
| 6 | 0–14 | Within expected (0–14) | |
| 17 | 0–14 | Above expected (0–14) | |
| 36 | 0–31 | Above expected (0–31) | |
| 14 | 0–33 | Within expected (0–33) | |
| 39 | 0–34 | Above expected (0–34) | |
| 38 | 0–46 | Within expected (0–46) | |
| 29 | 1–48 | Within expected (1–48) | |
| 38 | 3–55 | Within expected (3–55) | |
| 30 | 7–67 | Within expected (7–67) | |
| 32 | 6–53 | Within expected (6–53) | |
| 33 | 8–58 | Within expected (8–58) |
21 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 DRX.
What are the predicate devices in DRX?
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 DRX?
Across the 329 most recent decisions, these applicants filed most often in DRX.
| Applicant | Recent clearances |
|---|---|
| Graphic Controls Corp. | 17 |
| Nikomed U.S.A., Inc. | 12 |
| Lectec Corp. | 11 |
| Labeltape Meditect, Inc. | 10 |
| Andover Medical, Inc. | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in DRX files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Leonhard Lang Gmbh | 10 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch DRX
Get an email the morning anything changes in DRX — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Cardiovascular
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.