FDA product code PQX: Epinephrine Syringe
PQX is the FDA product code for epinephrine syringe. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under PQX. The average 510(k) review took 280 days (median 280).
Definition
Intended for intramuscular or subcutaneous injection of epinephrine.
Classification
| Field | Value |
|---|---|
| Device name | Epinephrine Syringe |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for PQX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 324 |
| 2018 | 1 | 237 |
Compare with all 510(k) review times · Search every PQX clearance
Top PQX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Certa Dose, Inc. | 2 | 2018-11-07 |
Most recent PQX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180683 | Certa Dose, Inc. | Certa Dose Pediatric Midazolam 5mg/mL IM Syringe | 2018-11-07 | 237 |
| K160589 | Certa Dose, Inc. | Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe | 2017-01-19 | 324 |
Recalls for PQX devices
openFDA lists no recalls for product code PQX.
Frequently asked questions
What is FDA product code PQX?
PQX is the FDA product code for epinephrine syringe. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is PQX?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQX?
Across 2 cleared submissions the average was 280 days from receipt to decision (median 280).
Which companies have the most PQX clearances?
Certa Dose, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PQX
- Run a recall and safety report across every PQX manufacturer
- Watch product code PQX 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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