PQX
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Epinephrine Syringe
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Medical specialty
- General Hospital
- FDA definition
- Intended for intramuscular or subcutaneous injection of epinephrine.
- Adverse events (MAUDE)
- 2024: 20 · 2025: 28 · 2026: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Certa Dose Pediatric Midazolam 5mg/mL IM Syringe (K180683) | Certa Dose, Inc. | 2018-11-07 |
| Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe (K160589) | Certa Dose, Inc. | 2017-01-19 |
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Every clearance here is in the API, with alerts when new ones post.