LGZ — Warmer, Thermal, Infusion Fluid Class II
FDA product code LGZ covers "Warmer, Thermal, Infusion Fluid", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LGZ
- Device Class
- Class II
- Regulation Number
- 880.5725
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260988 | mequ | °M Warmer System with °M Station | April 24, 2026 |
| K252636 | surgical company international | Fluido Compact System | November 18, 2025 |
| K251733 | surgical company international bv (as tsc life) | Fluido® AirGuard System | September 4, 2025 |
| K232107 | mequ | °M Warmer System | May 31, 2024 |
| K211618 | surgical company international | Fluido Compact Blood and Fluid Warming System | June 5, 2023 |
| K211800 | quality in flow | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior | December 8, 2022 |
| K202461 | smisson-cartledge biomedical | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion Sys | August 12, 2022 |
| K213191 | barkey gmbh and co. kg | S-Line | May 24, 2022 |
| K192325 | life warmer | Quantum Blood and Fluid Warming System | October 18, 2019 |
| K180842 | mac medical | MAC Medical D-Series Blanket and Solution Warming Cabinets | March 5, 2019 |
| K181775 | life warmer | Quantum Blood and IV Fluid Infusion Warmer | January 28, 2019 |
| K180154 | quality in flow | QiF Blood and Fluid Warmer | April 27, 2018 |
| K171215 | quality in flow | QiF Blood and Fluid Warmer | September 27, 2017 |
| K163708 | quality in flow | QiF Blood and Fluid Warmer | April 20, 2017 |
| K161613 | rand | Hang&Go PAC | December 28, 2016 |
| K150404 | quality in flow | QiF Blood and Fluid Warmer | June 23, 2016 |
| K152208 | belmont instrument corporation | The Belmont Hyperthermia Pump | September 2, 2015 |
| K150484 | creche innovations | Penguin In-Line Warmer | July 9, 2015 |
| K132202 | enthermics medical systems | DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET | December 6, 2013 |
| K131519 | belmont instrument | BELMONT HYPERTHERMIA PUMP | November 6, 2013 |