FDA product code DRQ: Amplifier And Signal Conditioner, Transducer Signal
DRQ is the FDA product code for amplifier and signal conditioner, transducer signal. It is a Class II device, regulated under 21 CFR 870.2060 and reviewed by the Cardiovascular panel. FDA has cleared 27 510(k) submissions under DRQ, from 22 different applicants. The average 510(k) review took 72 days (median 43). FDA has posted 1 recall for DRQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Amplifier And Signal Conditioner, Transducer Signal |
| Device class | Class II |
| Regulation | 21 CFR 870.2060 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DRQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 25 |
Compare with all 510(k) review times · Search every DRQ clearance
Top DRQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corporation | 2 | 2015-10-21 |
| C.R. Bard, Inc. | 2 | 2005-05-27 |
| Draeger Medical Systems, Inc. | 2 | 2005-04-29 |
| Siemens Medical Solutions USA, Inc. | 2 | 2002-02-19 |
| Sorensen Research | 2 | 1980-12-31 |
17 more applicants have DRQ clearances. See the full list in Caduvo.
Most recent DRQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172216 | Acist Medical Systems, Inc. | ACIST RXi Mini System | 2017-08-18 | 25 |
| K152693 | Boston Scientific Corporation | CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels | 2015-10-21 | 30 |
| K150235 | Boston Scientific Corporation | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels | 2015-04-22 | 79 |
| K050006 | C.R. Bard, Inc. | BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO | 2005-05-27 | 144 |
| K050974 | Draeger Medical Systems, Inc. | DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS | 2005-04-29 | 11 |
Recalls for DRQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-06-02.
Frequently asked questions
What is FDA product code DRQ?
DRQ is the FDA product code for amplifier and signal conditioner, transducer signal. It is a Class II device, regulated under 21 CFR 870.2060 and reviewed by the Cardiovascular panel.
What device class is DRQ?
Class II, regulation 21 CFR 870.2060. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRQ?
Across 27 cleared submissions the average was 72 days from receipt to decision (median 43).
Which companies have the most DRQ clearances?
Boston Scientific Corporation (2); C.R. Bard, Inc. (2); Draeger Medical Systems, Inc. (2); Siemens Medical Solutions USA, Inc. (2); Sorensen Research (2).
Have DRQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-06-02.
Next steps
- Run an FDA pathway report with predicate devices for product code DRQ
- Run a recall and safety report across every DRQ manufacturer
- Watch product code DRQ 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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