LZF · Pump, Infusion, Analytical Sampling
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | LZF |
|---|---|
| Device Name | Pump, Infusion, Analytical Sampling |
| 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192785 | OptiScanner® 5000 Glucose Monitoring System | Optiscan Biomedical Corporation | Feb 5, 2020 | SESE |
| K162042 | OptiScanner 5000 Glucose Monitoring System | Optiscan Biomedical Corp. | Oct 16, 2017 | SESE |
| K011238 | RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM | Metracor Technologies, Inc. | Jan 8, 2002 | SESE |
| K951739 | PUMP/BLOOD CHEMISTRY MONITOR | Via Medical Corp. | Feb 28, 1996 | SESE |
| K922997 | VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. | Via Medical Corp. | Jan 11, 1994 | SEKD |
| K920438 | VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM | Via Medical Corp. | Oct 22, 1993 | SEKD |
| K882830 | INFUSION PUMP | Pemlab Corp. | Dec 30, 1988 | SESE |
Top Applicants
- Via Medical Corp. — 3 clearances
- Metracor Technologies, Inc. — 1 clearance
- Optiscan Biomedical Corp. — 1 clearance
- Optiscan Biomedical Corporation — 1 clearance
- Pemlab Corp. — 1 clearance
