FDA product code DQB: Phlebograph, Impedance
DQB is the FDA product code for phlebograph, impedance. It is a Class II device, regulated under 21 CFR 870.2750 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under DQB, from 3 different applicants. The average 510(k) review took 82 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Phlebograph, Impedance |
| Device class | Class II |
| Regulation | 21 CFR 870.2750 |
| 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 DQB clearance
Top DQB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sonicaid, Inc. | 1 | 1985-05-16 |
| Eko Scann AB | 1 | 1983-03-24 |
| Dynatech Research & Development Co. | 1 | 1977-11-18 |
Most recent DQB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851102 | Sonicaid, Inc. | VASOSCREEN IMPEDANCE PLETHYSMOGRAPH | 1985-05-16 | 58 |
| K822873 | Eko Scann AB | DEVETHERM | 1983-03-24 | 178 |
| K772093 | Dynatech Research & Development Co. | IMPEDANCE RHEOGRAPH | 1977-11-18 | 11 |
Recalls for DQB devices
openFDA lists no recalls for product code DQB.
Frequently asked questions
What is FDA product code DQB?
DQB is the FDA product code for phlebograph, impedance. It is a Class II device, regulated under 21 CFR 870.2750 and reviewed by the Cardiovascular panel.
What device class is DQB?
Class II, regulation 21 CFR 870.2750. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQB?
Across 3 cleared submissions the average was 82 days from receipt to decision (median 58).
Which companies have the most DQB clearances?
Sonicaid, Inc. (1); Eko Scann AB (1); Dynatech Research & Development Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DQB
- Run a recall and safety report across every DQB manufacturer
- Watch product code DQB 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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