FDA product code DRX: Electrode, Electrocardiograph
DRX is the FDA product code for electrode, electrocardiograph. It is a Class II device, regulated under 21 CFR 870.2360 and reviewed by the Cardiovascular panel. FDA has cleared 329 510(k) submissions under DRX, from 146 different applicants. The average 510(k) review took 123 days (median 86). FDA has posted 20 recalls for DRX devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Electrocardiograph |
| Device class | Class II |
| Regulation | 21 CFR 870.2360 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
510(k) clearances per year for DRX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 117 |
Compare with all 510(k) review times · Search every DRX clearance
Top DRX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Graphic Controls Corp. | 17 | 1998-11-13 |
| Nikomed U.S.A., Inc. | 12 | 2003-01-09 |
| Lectec Corp. | 11 | 1993-04-16 |
| Labeltape Meditect, Inc. | 10 | 1990-09-04 |
| Leonhard Lang GmbH | 8 | 2009-08-21 |
141 more applicants have DRX clearances. See the full list in Caduvo.
Most recent DRX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171244 | Nimbleheart, Inc. | Physiotrace | 2017-08-23 | 117 |
| K140096 | Hmicro, Inc. | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE | 2014-07-24 | 191 |
| K123658 | Zephyr Technology Corporation | BIOMODULE 3-M1 | 2013-04-24 | 147 |
| K101576 | Team Innovations, Inc. | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES | 2010-07-22 | 45 |
| K101685 | Integral Process Sas | IP-SET | 2010-07-01 | 15 |
Recalls for DRX devices
20 product recalls in 10 recall events; 7 initiated in the last five years and 0 still open. Most recent: 2022-03-15.
| Year | Recalls |
|---|---|
| 2020 | 5 |
| 2021 | 1 |
| 2022 | 6 |
Frequently asked questions
What is FDA product code DRX?
DRX is the FDA product code for electrode, electrocardiograph. It is a Class II device, regulated under 21 CFR 870.2360 and reviewed by the Cardiovascular panel.
What device class is DRX?
Class II, regulation 21 CFR 870.2360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DRX?
Across 329 cleared submissions the average was 123 days from receipt to decision (median 86).
Which companies have the most DRX clearances?
Graphic Controls Corp. (17); Nikomed U.S.A., Inc. (12); Lectec Corp. (11); Labeltape Meditect, Inc. (10); Leonhard Lang GmbH (8).
Have DRX devices been recalled?
Yes: 20 product recalls across 10 recall events; the most recent began 2022-03-15.
Next steps
- Run an FDA pathway report with predicate devices for product code DRX
- Run a recall and safety report across every DRX manufacturer
- Watch product code DRX 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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