FDA product code DRR: Amplifier And Signal Conditioner, Biopotential
DRR is the FDA product code for amplifier and signal conditioner, biopotential. It is a Class II device, regulated under 21 CFR 870.2050 and reviewed by the Cardiovascular panel. FDA has cleared 24 510(k) submissions under DRR, from 18 different applicants. The average 510(k) review took 60 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Amplifier And Signal Conditioner, Biopotential |
| Device class | Class II |
| Regulation | 21 CFR 870.2050 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DRR clearance
Top DRR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hewlett-Packard Co. | 5 | 1980-11-26 |
| Quinton Electrophysiology Corp. | 2 | 1997-12-29 |
| Astro-Med, Inc. | 2 | 1989-09-18 |
| Biocheck, Inc. | 1 | 2002-12-19 |
| Mennen Medical, Inc. | 1 | 1992-01-28 |
13 more applicants have DRR clearances. See the full list in Caduvo.
Most recent DRR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022660 | Biocheck, Inc. | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | 2002-12-19 | 132 |
| K971570 | Quinton Electrophysiology Corp. | EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 | 1997-12-29 | 244 |
| K925346 | Quinton Electrophysiology Corp. | EP AMP, MODEL #901 | 1993-04-30 | 190 |
| K914381 | Mennen Medical, Inc. | HORIZON 9000/HIS OPTION AMPLIFIER | 1992-01-28 | 117 |
| K911935 | Gould, Inc. | CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED | 1991-07-22 | 82 |
Recalls for DRR devices
openFDA lists no recalls for product code DRR.
Frequently asked questions
What is FDA product code DRR?
DRR is the FDA product code for amplifier and signal conditioner, biopotential. It is a Class II device, regulated under 21 CFR 870.2050 and reviewed by the Cardiovascular panel.
What device class is DRR?
Class II, regulation 21 CFR 870.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRR?
Across 24 cleared submissions the average was 60 days from receipt to decision (median 30).
Which companies have the most DRR clearances?
Hewlett-Packard Co. (5); Quinton Electrophysiology Corp. (2); Astro-Med, Inc. (2); Biocheck, Inc. (1); Mennen Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DRR
- Run a recall and safety report across every DRR manufacturer
- Watch product code DRR 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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