Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725) → FRN — Pump, Infusion # FRN · Pump, Infusion _General Hospital · 21 CFR 880.5725 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN ## Overview - **Product Code:** FRN - **Device Name:** Pump, Infusion - **Regulation:** [21 CFR 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K252015.md) | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. | Jan 28, 2026 | SESE | | [K251640](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K251640.md) | SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | Jul 28, 2025 | SESE | | [K251636](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K251636.md) | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation | Jul 28, 2025 | SESE | | [K242752](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K242752.md) | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | May 28, 2025 | SESE | | [K243855](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K243855.md) | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | Apr 25, 2025 | SESE | | [K242115](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K242115.md) | Plum Duo™ Precision IV Pump | Icu Medical, Inc. | Apr 2, 2025 | SESE | | [K242114](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K242114.md) | Plum Solo™ Precision IV Pump | Icu Medical, Inc. | Apr 2, 2025 | SESE | | [K250357](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K250357.md) | RemunityPRO™ Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | Mar 11, 2025 | SESE | | [K241736](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K241736.md) | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. | Jan 16, 2025 | SESE | | [K242735](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K242735.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K242660.md) | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets | Zevex, Inc. | Oct 3, 2024 | SESE | | [K242390](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K242390.md) | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | Sep 5, 2024 | SESE | | [K232793](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K232793.md) | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets | Zevex, Inc. | May 17, 2024 | SESE | | [K211122](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K211122.md) | Novum IQ Large Volume Pump | Baxter Healthcare Corporation | Mar 29, 2024 | SESE | | [K231918](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K231918.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K230083.md) | SAFIRA | Medovate Limited | Oct 31, 2023 | SESE | | [K223607](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K223607.md) | Plum Duo™ Infusion System | Icu Medical, Inc. | Aug 24, 2023 | SESE | | [K211218](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K211218.md) | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | Jul 21, 2023 | SESE | | [K230041](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K230041.md) | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | Mar 31, 2023 | SESE | | [K230022](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K230022.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com