FDA product code DRJ: System, Signal Isolation
DRJ is the FDA product code for system, signal isolation. It is a Class I device, regulated under 21 CFR 870.2600 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under DRJ, from 2 different applicants. The average 510(k) review took 77 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | System, Signal Isolation |
| Device class | Class I |
| Regulation | 21 CFR 870.2600 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DRJ clearance
Top DRJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Honeywell, Inc. | 3 | 1982-10-04 |
| Clinical Data Instruments, Inc. | 1 | 1984-05-09 |
Most recent DRJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832828 | Clinical Data Instruments, Inc. | CENTURION CARDIAC DETECTOR | 1984-05-09 | 264 |
| K822590 | Honeywell, Inc. | PRESSURE ISOLATION AMPLIFIER #9813 517 | 1982-10-04 | 27 |
| K771685 | Honeywell, Inc. | AMPLIFIER MODEL N5A-HIS | 1977-09-14 | 8 |
| K771684 | Honeywell, Inc. | AMPLIFIER MODEL N5A-ECG | 1977-09-14 | 8 |
Recalls for DRJ devices
openFDA lists no recalls for product code DRJ.
Frequently asked questions
What is FDA product code DRJ?
DRJ is the FDA product code for system, signal isolation. It is a Class I device, regulated under 21 CFR 870.2600 and reviewed by the Cardiovascular panel.
What device class is DRJ?
Class I, regulation 21 CFR 870.2600. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DRJ?
Across 4 cleared submissions the average was 77 days from receipt to decision (median 18).
Which companies have the most DRJ clearances?
Honeywell, Inc. (3); Clinical Data Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DRJ
- Run a recall and safety report across every DRJ manufacturer
- Watch product code DRJ 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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