FRN · Pump, Infusion
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | FRN |
|---|---|
| Device Name | Pump, Infusion |
| 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 (20 of 848)
Showing 20 most recent of 848 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. | Jan 28, 2026 | SESE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | Jul 28, 2025 | SESE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation | Jul 28, 2025 | SESE |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | May 28, 2025 | SESE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | Apr 25, 2025 | SESE |
| K242115 | Plum Duo Precision IV Pump | Icu Medical, Inc. | Apr 2, 2025 | SESE |
| K242114 | Plum Solo Precision IV Pump | Icu Medical, Inc. | Apr 2, 2025 | SESE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | Mar 11, 2025 | SESE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. | Jan 16, 2025 | SESE |
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) | Belmont Medical Technologies | Dec 23, 2024 | SESE |
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets | Zevex, Inc. | Oct 3, 2024 | SESE |
| K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | Sep 5, 2024 | SESE |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets | Zevex, Inc. | May 17, 2024 | SESE |
| K211122 | Novum IQ Large Volume Pump | Baxter Healthcare Corporation | Mar 29, 2024 | SESE |
| K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter | Koru Medical Systems | Nov 3, 2023 | SESE |
| K230083 | SAFIRA | Medovate Limited | Oct 31, 2023 | SESE |
| K223607 | Plum Duo Infusion System | Icu Medical, Inc. | Aug 24, 2023 | SESE |
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | Jul 21, 2023 | SESE |
| K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | Mar 31, 2023 | SESE |
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | Mar 31, 2023 | SESE |
Top Applicants
- Abbott Laboratories — 66 clearances
- Baxter Healthcare Corp — 39 clearances
- Y — 26 clearances
- Travenol Laboratories, S.A. — 23 clearances
- C.R. Bard, Inc. — 22 clearances
