LGZ · Warmer, Thermal, Infusion Fluid
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | LGZ |
|---|---|
| Device Name | Warmer, Thermal, Infusion Fluid |
| 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 75)
Showing 20 most recent of 75 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260988 | °M Warmer System with °M Station | Mequ A/S | Apr 24, 2026 | SESE |
| K252636 | Fluido Compact System | The Surgical Company International B.V. | Nov 18, 2025 | SESE |
| K251733 | Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) | Sep 4, 2025 | SESE |
| K232107 | °M Warmer System | Mequ A/S | May 31, 2024 | SESE |
| K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | Jun 5, 2023 | SESE |
| K211800 | 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 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System | Smisson-Cartledge Biomedical, LLC | Aug 12, 2022 | SESE |
| K213191 | S-Line | Barkey GmbH & Co. KG | May 24, 2022 | SESE |
| K192325 | Quantum Blood and Fluid Warming System | Life Warmer, Inc. | Oct 18, 2019 | SESE |
| K180842 | MAC Medical D-Series Blanket and Solution Warming Cabinets | Mac Medical, Inc. | Mar 5, 2019 | SESE |
| K181775 | Quantum Blood and IV Fluid Infusion Warmer | Life Warmer, Inc. | Jan 28, 2019 | SESE |
| K180154 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | Apr 27, 2018 | SESE |
| K171215 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | Sep 27, 2017 | SESE |
| K163708 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | Apr 20, 2017 | SESE |
| K161613 | Hang&Go PAC | Rand S.R.L. | Dec 28, 2016 | SESE |
| K150404 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | Jun 23, 2016 | SESE |
| K152208 | The Belmont Hyperthermia Pump | Belmont Instrument Corporation | Sep 2, 2015 | SESE |
| K150484 | Penguin In-Line Warmer | Creche Innovations | Jul 9, 2015 | SESE |
| K132202 | DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET | Enthermics Medical Systems, Inc. | Dec 6, 2013 | SESE |
| K131519 | 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
