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) → LGZ — Warmer, Thermal, Infusion Fluid # LGZ · Warmer, Thermal, Infusion Fluid _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/LGZ ## Overview - **Product Code:** LGZ - **Device Name:** Warmer, Thermal, Infusion Fluid - **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 75) Showing 20 most recent of 75 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260988](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K260988.md) | °M Warmer System with °M Station | Mequ A/S | Apr 24, 2026 | SESE | | [K252636](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K252636.md) | Fluido Compact System | The Surgical Company International B.V. | Nov 18, 2025 | SESE | | [K251733](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K251733.md) | Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) | Sep 4, 2025 | SESE | | [K232107](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K232107.md) | °M Warmer System | Mequ A/S | May 31, 2024 | SESE | | [K211618](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K211618.md) | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | Jun 5, 2023 | SESE | | [K211800](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K211800.md) | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer | Quality IN Flow , Ltd. | Dec 8, 2022 | SESE | | [K202461](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K202461.md) | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System | Smisson-Cartledge Biomedical, LLC | Aug 12, 2022 | SESE | | [K213191](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K213191.md) | S-Line | Barkey GmbH & Co. KG | May 24, 2022 | SESE | | [K192325](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K192325.md) | Quantum Blood and Fluid Warming System | Life Warmer, Inc. | Oct 18, 2019 | SESE | | [K180842](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K180842.md) | MAC Medical D-Series Blanket and Solution Warming Cabinets | Mac Medical, Inc. | Mar 5, 2019 | SESE | | [K181775](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K181775.md) | Quantum Blood and IV Fluid Infusion Warmer | Life Warmer, Inc. | Jan 28, 2019 | SESE | | [K180154](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K180154.md) | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | Apr 27, 2018 | SESE | | [K171215](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K171215.md) | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | Sep 27, 2017 | SESE | | [K163708](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K163708.md) | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | Apr 20, 2017 | SESE | | [K161613](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K161613.md) | Hang&Go PAC | Rand S.R.L. | Dec 28, 2016 | SESE | | [K150404](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K150404.md) | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | Jun 23, 2016 | SESE | | [K152208](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K152208.md) | The Belmont Hyperthermia Pump | Belmont Instrument Corporation | Sep 2, 2015 | SESE | | [K150484](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K150484.md) | Penguin In-Line Warmer | Creche Innovations | Jul 9, 2015 | SESE | | [K132202](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K132202.md) | DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET | Enthermics Medical Systems, Inc. | Dec 6, 2013 | SESE | | [K131519](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ/K131519.md) | BELMONT HYPERTHERMIA PUMP | Belmont Instrument Corp. | Nov 6, 2013 | SESE | ## Top Applicants - Belmont Instrument Corp. — 5 clearances - Quality IN Flow , Ltd. — 5 clearances - C.F. Electronics, Inc. — 3 clearances - Medical Solutions, Inc. — 3 clearances - STERIS Corporation — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGZ) **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