Product code LGZ
- Device name
- Warmer, Thermal, Infusion Fluid
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5725
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260988 | °M Warmer System with °M Station | Mequ A/S | 2026-04-24 |
| K252636 | Fluido Compact System | The Surgical Company International B.V. | 2025-11-18 |
| K251733 | Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) | 2025-09-04 |
| K232107 | °M Warmer System | Mequ A/S | 2024-05-31 |
| K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | 2023-06-05 |
| K211800 | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2022-12-08 |
| K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System | Smisson-Cartledge Biomedical, LLC | 2022-08-12 |
| K213191 | S-Line | Barkey GmbH & Co. KG | 2022-05-24 |
| K192325 | Quantum Blood and Fluid Warming System | Life Warmer, Inc. | 2019-10-18 |
| K180842 | MAC Medical D-Series Blanket and Solution Warming Cabinets | Mac Medical, Inc. | 2019-03-05 |
| K181775 | Quantum Blood and IV Fluid Infusion Warmer | Life Warmer, Inc. | 2019-01-28 |
| K180154 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2018-04-27 |
| K171215 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2017-09-27 |
| K163708 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2017-04-20 |
| K161613 | Hang&Go PAC | Rand S.R.L. | 2016-12-28 |
| K150404 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2016-06-23 |
| K152208 | The Belmont Hyperthermia Pump | Belmont Instrument Corporation | 2015-09-02 |
| K150484 | Penguin In-Line Warmer | Creche Innovations | 2015-07-09 |
| K132202 | DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET | Enthermics Medical Systems, Inc. | 2013-12-06 |
| K131519 | BELMONT HYPERTHERMIA PUMP | Belmont Instrument Corp. | 2013-11-06 |
| K132110 | NATUS WARMETTE BLANKET AND DUAL CABINETS | Natus Nicolet Ireland, Ltd. | 2013-10-03 |
| K130867 | ENFLOW IV FLUID WARMER INSULATED STRAP | Vital Signs, Inc., A GE Healthcare Company | 2013-06-14 |
| K122449 | ENTERAL NUTRITION WARMER | Acacia, Inc. | 2013-06-13 |
| K121775 | ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER | Vital Signs, Inc., A GE Healthcare Company | 2012-11-28 |
| K121198 | BW685, BW685S | Biegler GmbH | 2012-07-12 |
| K120860 | INFU BOX TYPE 0412A | Medical Rescue Equipment Holding AS | 2012-05-08 |
| K120026 | PERFORMER HT/ HANG&GO HT BASIC | Rand S.R.L. | 2012-05-08 |
| K112702 | IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS | Imperial Surgical , Ltd. | 2012-03-29 |
| K102900 | HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM | Hei, Inc. | 2012-03-21 |
| K112902 | ENFLOW IV FLUID WARMER | Vital Signs, Inc. | 2012-03-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08719867002752 | Fluido® AirGuard System | The Surgical Company International B.V. | 2025-09-12 |
| 18719867002247 | Fluido® AirGuard System | The Surgical Company International B.V. | 2025-09-12 |
| 07613327626391 | ThermaClear | STRYKER CORPORATION | 2025-04-04 |
| 17290016740209 | QINFLOW AC STATION INTRO SET EXTREME | QUALITY IN FLOW LTD | 2025-02-18 |
| 09008247000235 | Extension Set | Biegler GmbH | 2024-06-04 |
| 09008247000242 | Extension Set | Biegler GmbH | 2024-06-04 |
| 18719867001806 | Fluido® Compact | The Surgical Company International B.V. | 2024-02-09 |
| 18719867001776 | Fluido® Compact | The Surgical Company International B.V. | 2024-02-09 |
| 18719867001561 | Fluido® Compact | The Surgical Company International B.V. | 2024-02-09 |
| 17290016740162 | QinFlow Warrior Lite set with 1 Lite Extra Power Battery | QUALITY IN FLOW LTD | 2023-01-05 |
| 17290016740049 | QINFLOW WARRIOR HYBRID INTRO SET | QUALITY IN FLOW LTD | 2023-01-04 |
| 10707387792722 | 3M™ Ranger™ | 3M COMPANY | 2021-06-21 |
| 10190752147102 | enFlow™ | AIRLIFE | 2021-03-29 |
| 10190752178281 | enFlow™ | AIRLIFE | 2021-03-29 |
| 09008247000259 | Extension Set | Biegler GmbH | 2020-06-19 |
| 08809220581007 | 2 Linking Screws | SOOIL DEVELOPMENT CO.,LTD | 2018-05-24 |
| 17290016740032 | QinFlow portable warmer system | QUALITY IN FLOW LTD | 2017-07-11 |
| 10695085002819 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 08809220581045 | DANA Diabecare | SOOIL DEVELOPMENT CO.,LTD | 2016-10-06 |
| 10885403286155 | enFlow | Carefusion Corporation | 2016-09-27 |
| 10896128002005 | 3.0 Liter Reservoir (6 Count) | BELMONT INSTRUMENT CORPORATION | 2016-09-23 |
| 10896128002012 | The Belmont® Rapid Infuser FMS2000 | BELMONT INSTRUMENT CORPORATION | 2016-09-23 |
| 10896128002029 | 3-Spike Disposable Set | BELMONT INSTRUMENT CORPORATION | 2016-09-23 |
| 10896128002067 | Patient Line Extension | BELMONT INSTRUMENT CORPORATION | 2016-09-23 |
| 10896128002081 | Fluid Replacement Supply | BELMONT INSTRUMENT CORPORATION | 2016-09-23 |
| 08809220581052 | DANA Easy Setter | SOOIL DEVELOPMENT CO.,LTD | 2016-09-23 |
| 08809220581014 | 3.6V Battery | SOOIL DEVELOPMENT CO.,LTD | 2016-09-23 |
| 08809220580994 | 2 Syringe Caps and 2 Battery Caps | SOOIL DEVELOPMENT CO.,LTD | 2016-09-23 |
| 10885403296864 | enFlow | Carefusion Corporation | 2016-09-21 |
| 10885403286162 | enFlow | Carefusion Corporation | 2016-09-21 |