QJY
- Product code
- QJY
- Device name
- Infusion Pump, Drug Specific, Pharmacy-Filled
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 4 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243354 | 2024-11-27 | Deka Research & Development Corp. | Remunity System | |
| K240256 | 2024-06-12 | Deka Research and Development | Remunity System |
Official FDA classification page: QJY
Classification and pathway per current FDA publications. Data from openFDA (CC0).