QJY
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Infusion Pump, Drug Specific, Pharmacy-Filled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- FDA definition
- A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.
- Adverse events (MAUDE)
- 2022: 22 · 2023: 61 · 2024: 43 · 2025: 155 · 2026: 66
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 |
|---|---|---|
| Remunity System (K243354) | Deka Research & Development Corp. | 2024-11-27 |
| Remunity System (K240256) | Deka Research and Development | 2024-06-12 |
| Remunity Pump for Remodulin (treprostinil) Injection (K202690) | Deka Research and Development | 2020-12-30 |
| Unity Subcutaneous Infusion System for Remodulin (K191313) | DEKA Research & Development | 2020-02-21 |
Track QJY automatically
Every clearance here is in the API, with alerts when new ones post.