← Product Code [LGZ](/productcode/LGZ) · K260988 # °M Warmer System with °M Station (K260988) _Mequ A/S · LGZ · Apr 24, 2026 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260988 ## Device Facts - **Applicant:** Mequ A/S - **Product Code:** [LGZ](/productcode/LGZ.md) - **Decision Date:** Apr 24, 2026 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 880.5725 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The °M Warmer System with °M Station is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical, and field environments to help prevent hypothermia. The field environment includes road ambulances. ## Device Story The °M Warmer System is an in-line fluid warming device. It consists of a sterile, single-use disposable warmer unit and the °M Station, a reusable AC mains power supply. The warmer features a parylene-coated aluminum heating chamber with resistive heating elements. It is inserted into an infusion line to warm fluids (blood, colloids, crystalloids) to 39±3°C at flow rates up to 150ml/min. The device is operated by healthcare professionals in clinical or field settings (road ambulances). Electronics and software within the warmer monitor temperature via two redundant sensors and control the heating process. Visual LED indicators provide alerts for overheat, under-heat, and low battery conditions. The system helps prevent hypothermia during fluid administration in medical emergencies or surgeries. ## Clinical Evidence Bench testing only. Testing included electrical safety and EMC compliance per IEC 60601-1 (Ed 3.2), IEC 60601-1-2 (Ed 4.1), and IEC 60601-1-12 (Ed 1.1). Performance data confirmed the system maintains fluid temperature at 39±3°C at 150ml/min flow rates, consistent with the predicate device. ## Technological Characteristics In-line fluid warmer; resistive heating elements; parylene-coated anodized aluminum heating chamber; silicone gaskets; plastic tubing. Complies with ASTM 2172:2002. Powered by AC mains (via °M Station) or rechargeable battery. Software-controlled temperature regulation. Visual LED status/alarm indicators. Two redundant temperature sensors for alarm monitoring. Sterilized disposable unit. ## Regulatory 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. ## Predicate Devices - °M Warmer System ([K232107](/device/K232107.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION April 24, 2026 MEQU A/S Lene Margrete Moesby Senior Regulatory Affairs Specialist Fruebjergvej 3 2100 Ø København Ø Denmark Re: K260988 Trade/Device Name: °M Warmer System with °M Station Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, BSB Dated: March 25, 2026 Received: March 25, 2026 Dear Lene Margrete Moesby: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260988 - Lene Margrete Moesby Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K260988 - Lene Margrete Moesby Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jake K. Lindstrom -S Jake Lindstrom, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K260988 | | | Device Name °M Warmer System with °M Station | | | Indications for Use (Describe) The °M Warmer System with °M Station is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical, and field environments to help prevent hypothermia. The field environment includes road ambulances. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} Page 1 of 5 # K260988 510(k) Summary Submitter: MEQU A/S Address: Fruebjergvej 3 København Ø 2100 Denmark Phone number: +45 3110 5487 Contact person: Mrs. Lene Margrete Moesby Date prepared: 22 Apr 2026 Trade name: °M Warmer System with °M Station Common name: In-line infusion fluid warmer Classification name: Warmer, Thermal Infusion Liquid (21 CFR 880.5725, product code LGZ) Warmer, Blood, Non-Electromagnetic Radiation (21 CFR, 864.9205, product code BSB) Substantial equivalence is claimed to: °M Warmer System (K232107) {5} Page 2 of 5 # Purpose of 510(k) The purpose of this 510(k) is to add the °M Station as an additional AC mains power source to the °M Warmer in the °M Warmer System. # Indications for use The °M Warmer System with °M Station is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical, and field environments to help prevent hypothermia. The field environment includes road ambulances. # Device Description The °M Warmer System with °M Station consists of: 1. °M Warmer – A single-use, sterile, disposable in-line fluid warming unit 2. °M Station – A new multi-patient, reusable AC mains power supply providing continuous power to the °M Warmer during use. The warmer contains a sterile fluid path with standard Luer lock connectors allowing it to be connected in the infusion fluid line. The fluid path includes a parylene coated aluminum heating chamber in which fluids passing through the warmer are heated. Heat is generated using resistive heating elements, using power supplied by the rechargeable battery pack. The warmer contains the electronics and software to control the temperature of the chamber and thus the temperature of the outgoing fluid. The °M Station is a transportable accessory designed to be used as an AC mains power supply for the °M Warmer in hospital/clinic settings or in ground-based ambulances. # Substantial equivalence The subject device °M Warmer System with °M Station is substantially equivalent to the cleared °M Warmer System. Both the cleared device and the °M Warmer System with °M Station is a portable IV fluid warming system. The differences between the predicate and subject device do not raise any concerns regarding safety and effectiveness and equivalent performance have been demonstrated. Thus, °M Warmer System with M Station is substantially equivalent. A detailed comparison between the predicate and the subject device is provided in the table below: {6} | | °M Warmer System with °M Station (Subject device) | °M Warmer System (K232107) | Comparison | | --- | --- | --- | --- | | Indications for Use | The °M Warmer System with °M Station is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road ambulances. | The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances. | Difference: °M Warmer System with °M Station is more specific in the supported field environment in the indications for use. | | Intended use | Medical emergencies or surgeries where warm fluid administration is required to treat the patient. Whenever parenteral introduction of normothermic fluid is desired or indicated | Medical emergencies or surgeries where warm fluid administration is required to treat the patient. Whenever parenteral introduction of normothermic fluid is desired or indicated | Same | | User population | Healthcare professional (i.e. paramedic, nurse doctor etc.) | Healthcare professional (i.e. paramedic, nurse doctor etc.) | Same | | User Interface / Notifications | Visual (LED) | Visual (LED) | Same | | Notification Types | Overheat Under heat Low battery | Overheat Under heat Low battery | Same | | Alarm Sensor | Two redundant temperature sensors. | Two redundant temperature sensors. | Same | | Alarm Condition / Alarm indicators | Visual (RED LED) instantaneous activated from 43 °C. | Visual (RED LED) instantaneous activated from 43 °C. | Same | | Usage Environment | Clinic and Field. The field environment includes road ambulances. | Clinic and Field. The field environment includes road, rotary and fixed-wing ambulances. | Difference: °M Warmer System with °M Station is more specific in the supported field environment. | Page 3 of 5 {7} | | °M Warmer System with °M Station (Subject device) | °M Warmer System (K232107) | Comparison | | --- | --- | --- | --- | | Components | - Disposable warmer with integrated fluid path - Power source (AC mains) | - Disposable warmer with integrated fluid path - Power source (rechargeable battery pack) - Charger | Difference: The °M Warmer System with °M Station is operated with AC mains power supply. | | Infusion temperature | 39±3°C @ 150ml/min at 5°C input temperature | 39±3°C @ 150ml/min at 5°C input temperature | Same | | Flow Rate | Up to 150ml/min at 5°C input temperature | Up to 150ml/min at 5°C input temperature | Same | | Operating Environment | 15 % RH to 95 % RH (relative humidity). Temperature range of 0°C to +40°C; non-condensing. | 15 % RH to 95 % RH (relative humidity). Temperature range of 0°C to +40°C; non-condensing. | Same | | Heating technology | Software-controlled resistive heating | Software-controlled resistive heating | Same | | Fluid path | Sterile fluid path consisting of plastic tubing, silicone gasket and biocompatible parylene coated anodized aluminum. | Sterile fluid path consisting of plastic tubing, silicone gasket and biocompatible parylene coated anodized aluminum. | Same | | Warmer type | Inline | Inline | Same | | Power Source | AC mains power supply | Rechargeable battery | Difference: AC mains power supply was added as an additional power source for the °M Warmer | | Biocompatibility | The fluid path is made of biocompatible parylene coated anodized aluminum. | The fluid path is made of biocompatible parylene coated anodized aluminum. | Same | | Software | The software control the heating process and the operation of the device. | The software control the heating process and the operation of the device. | Same | | Sterility | The disposable unit is provided sterile for single patient use. | The disposable unit is provided sterile for single patient use. | Same | | Product specific Standard with which the Device Complies | ASTM 2172:2002, Standard specification for blood/Intravenous Fluid Irrigation Fluid Warmers | ASTM 2172:2002, Standard specification for blood/Intravenous Fluid Irrigation Fluid Warmers | Same | Performance data from non-clinical studies {8} The following non-clinical testing was conducted to demonstrate substantial equivalence to the predicate device: ## Bench testing Electrical Safety and EMC testing was performed in accordance with - IEC 60601-1 Edition 3.2 2020-08 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" - IEC 60601-1-2 Edition 4.1 2020-09 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests" - IEC 60601-1-12 Edition 1.1 2020-07 "Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment" In all instances, the subject device functioned as intended and demonstrated equivalent performance to the predicate device. ## Conclusion The modifications to the °M Warmer System by adding a °M Station (AC mains power supply) do not raise different questions of safety and effectiveness and are supported by risk management activities. Based on the equivalence to the predicate device, and the results of the non-clinical performance data, MEQU A/S find that the °M Warmer System with °M Station is as safe, as effective, and performs as well as the predicate device cleared under K232107. Page 5 of 5 --- **Source:** [https://fda.innolitics.com/device/K260988](https://fda.innolitics.com/device/K260988) **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. 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