PMS · Peripheral Intravenous (Piv) Infiltration Monitor
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | PMS |
|---|---|
| Device Name | Peripheral Intravenous (Piv) Infiltration Monitor |
| 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233881 | ivWatch® Model 400 | Ivwatch, LLC | Mar 15, 2024 | SESE |
| K222212 | ivWatch Model 400 | Ivwatch, LLC | Aug 24, 2022 | SESE |
| K192385 | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable | Ivwatch, LLC | Jul 2, 2020 | SESE |
| K162478 | ivWatch | Ivwatch, LLC | Dec 22, 2016 | SESE |
| K153605 | ivWatch Model 400 | Ivwatch, LLC | Feb 11, 2016 | SESE |
Top Applicants
- Ivwatch, LLC — 5 clearances
