FDA product code DQF: Actuator, Syringe, Injector Type
DQF is the FDA product code for actuator, syringe, injector type. It is a Class II device, regulated under 21 CFR 870.1670 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under DQF, from 3 different applicants. The average 510(k) review took 113 days (median 130).
Classification
| Field | Value |
|---|---|
| Device name | Actuator, Syringe, Injector Type |
| Device class | Class II |
| Regulation | 21 CFR 870.1670 |
| Review panel | HO — General Hospital |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DQF clearance
Top DQF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bioteque America, Inc. | 1 | 1992-07-13 |
| Alcon Laboratories | 1 | 1988-11-08 |
| Spectramed, Inc. | 1 | 1988-03-22 |
Most recent DQF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920177 | Bioteque America, Inc. | VERSA-VIAL | 1992-07-13 | 181 |
| K882723 | Alcon Laboratories | ALCON FLUID INJECTOR | 1988-11-08 | 130 |
| K880740 | Spectramed, Inc. | MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE | 1988-03-22 | 27 |
Recalls for DQF devices
openFDA lists no recalls for product code DQF.
Frequently asked questions
What is FDA product code DQF?
DQF is the FDA product code for actuator, syringe, injector type. It is a Class II device, regulated under 21 CFR 870.1670 and reviewed by the General Hospital panel.
What device class is DQF?
Class II, regulation 21 CFR 870.1670. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQF?
Across 3 cleared submissions the average was 113 days from receipt to decision (median 130).
Which companies have the most DQF clearances?
Bioteque America, Inc. (1); Alcon Laboratories (1); Spectramed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DQF
- Run a recall and safety report across every DQF manufacturer
- Watch product code DQF 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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