QJY · Infusion Pump, Drug Specific, Pharmacy-Filled
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | QJY |
|---|---|
| Device Name | Infusion Pump, Drug Specific, Pharmacy-Filled |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243354 | Remunity System | Deka Research & Development Corp. | Nov 27, 2024 | SESE |
| K240256 | Remunity System | Deka Research and Development | Jun 12, 2024 | SESE |
| K202690 | Remunity Pump for Remodulin (treprostinil) Injection | Deka Research and Development | Dec 30, 2020 | SESE |
| K191313 | Unity Subcutaneous Infusion System for Remodulin | DEKA Research & Development | Feb 21, 2020 | SESE |
Top Applicants
- Deka Research and Development — 2 clearances
- DEKA Research & Development — 1 clearance
- Deka Research & Development Corp. — 1 clearance
