← Product Code [DWJ](/productcode/DWJ) · K261437 # Mistral-Air® Warming System (K261437) _The Surgical Company International B.V., doing business as TSC Life · DWJ · Aug 7, 2026 · Cardiovascular · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K261437 ## Device Facts - **Applicant:** The Surgical Company International B.V., doing business as TSC Life - **Product Code:** [DWJ](/productcode/DWJ.md) - **Decision Date:** Aug 7, 2026 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.5900 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic, Pediatric ## Indications for Use The Mistral-Air® Warming System is a forced air warming system that comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming. ## Device Story Forced air warming system; comprises reusable warming unit (MA1400) and disposable blankets. Unit draws air through filter; heats via internal element; propels warm air through flexible hose into blanket draped on, around, or under patient. Heat transfer via convection; blanket provides insulation. Operated manually via control panel by clinicians in healthcare settings. Maintains patient temperature; prevents inadvertent hypothermia. System requires use of specific Mistral-Air blankets for safety and performance. ## Clinical Evidence No clinical data. Evidence consists of nonclinical safety data including electrical safety, electromagnetic compatibility, software verification and validation, mechanical and durability assessments, lifecycle and packaging evaluations, human factors evaluation, and risk management activities. ## Technological Characteristics Electrically powered (100-125 V AC, 50/60Hz). Components: reusable warming unit, flexible hose, disposable blankets. Materials: metal, electronics, ABS/PC. Convection-based warming. Manual control panel operation. Software-controlled heating and airflow regulation. ## Regulatory Identification A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature. ## Predicate Devices - Mistral-Air® Warming System (MA1200) ([K171234](/device/K171234.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 August 7, 2026 The Surgical Company International B.V., doing business as TSC Life Gianpaolo Soares RA Project Manager Paalbergweg 3 Noord-Holland Amsterdam, 1105 AG Netherlands Re: K261437 Trade/Device Name: Mistral-Air® Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: July 10, 2026 Received: July 10, 2026 Dear Gianpaolo Soares: 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261437 - Gianpaolo Soares Page 2 (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-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). {2} K261437 - Gianpaolo Soares Page 3 Sincerely, **KATHLEEN M. GRUNDER -S** for Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural, and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261437 | ? | | Please provide the device trade name(s). | | ? | | Mistral-Air® Warming System | | | | Please provide your Indications for Use below. | | ? | | The Mistral-Air® Warming System is indicated for patient warming in situations where prevention of inadvertent hypothermia is required. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☑ Neonates/Newborns (Birth to < 29 days old) ☑ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} TSC LIFE K261437 Innovation with purpose Submitter Name and Address The Surgical Company International B.V., doing business as TSC Life Paalbergweg 3 Amsterdam, 1105 AG The Netherlands Contact Person Name: Gianpaolo Soares Title: Regulatory Affairs Project Manager, TSC Life Company Telephone: 765-205-6030 Email: fda.tsclife-us@tsc-life.com Device Information Name of Device: Mistral-Air® Warming System Model: MA1400 (Warming Unit) Common or Usual Name: Thermal regulating system Classification Name: System, Thermal Regulating, 21 CFR 870.5900 Regulatory Class: II Product Code: DWJ Predicate Information Same device as required for Special 510(k) pathway. Name of Predicate: Mistral-Air® Warming System Model: MA1200 (Warming Unit) 510(k) Number: K171234 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. Device Description The Mistral-Air® Warming System is comprised of a warming unit and blankets and is designed to warm patients using temperature-controlled filtered warm forced airflow. The device's blanket, which can be placed on top, around, or underneath a patient, guides the airflow towards the skin of the patient, where heat is transferred by convection. Additionally, this combination keeps the patient insulated. The warming unit generates and directs the warm air into the blankets. This controlled airflow ensures consistent and effective warming. For optimal safety and performance, warming unit and hose shall only be used with the Mistral-Air® blankets. Intended Use The Mistral-Air® Warming System is a forced air warming system that comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming. Indications for Use The Mistral-Air® Warming System is indicated for patient warming in situations where prevention of inadvertent hypothermia is required. The Surgical Company International B.V. | Paalbergweg 3 | 1105 AG Amsterdam | The Netherlands | T +31 20 7900 2100 | letsconnect@tsc-life.com www.tsc-life.com | CC no. 31029240 | VAT no. NL 8111.49.948.B03 | BANK: ING Commercial Banking | Bijlmerplein 888 | 1102 MG Amsterdam | The Netherlands IBAN NL15 INGB 0653 7522 02 | BIC: INGBNL2A Page | 2 {5} TSC LIFE Innovation with purpose Table 1: Comparison of Technological Characteristics | Subject | Predicate Device Mistral-Air® Warming System (with MA1200) | Subject Device Mistral-Air® Warming System (with MA1400) | Substantial Equivalence | | --- | --- | --- | --- | | Mode of Operation | Manual operation via control panel | Manual operation via control panel | Same | | Material of Mistral-Air® Warming Unit | Metal, electronics and ABS/PC | Metal, electronics and ABS/PC | Same | | Operating Principle | Electrically powered device (consisting of a control circuit, air filter, fan, heating element and temperature sensors) that propels warmed air via a flexible hose to a blanket (Sterile or Non-sterile, depending on the model) draped on or under the patient. | Electrically powered device (consisting of a control circuit, air filter, fan, heating element and temperature sensors) that propels warmed air via a flexible hose to a blanket (Sterile or Non-sterile, depending on the model) draped on or under the patient. | Same | | System Components | • Reuseable Warming unit • Disposable sterile and non-sterile blankets/suits | • Reuseable Warming unit • Disposable sterile and non-sterile blankets/suits | Same | | Warming Technology | Convection | Convection | Same | | Energy Source | 100-125 V AC, 50Hz/60Hz | 100-125 V AC, 50Hz/60Hz | Same | | Blanket Compatibility | Yes - Compatible with Mistral-Air® Warming Blankets | Yes - Compatible with Mistral-Air® Warming Blankets | Same | ### Performance Data Nonclinical safety data included electrical safety and electromagnetic compatibility evaluation, software verification and validation, mechanical and durability assessments, lifecycle and packaging evaluations, human factors evaluation, and risk management activities. Cybersecurity documentation was prepared in accordance with FDA's guidance 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions' (issued February 3, 2026). ### Conclusion The purpose of this Special 510(k) premarket notification is to introduce a new model of the Mistral-Air® Warming Unit (part of the Mistral-Air® Warming System). The results of the nonclinical evaluations conducted for this premarket notification demonstrate that the modified device is as safe and as effective as the legally marketed predicate device and performs as well as or better than the predicate. The proposed model change does not alter the device's intended use or fundamental technological characteristics, nor does it raise new questions of safety or effectiveness. The information provided supports a determination that the Mistral-Air® Warming System, including the MA1400 Warming Unit, is substantially equivalent to the predicate Mistral-Air® Warming System with the MA1200 Warming Unit cleared under K171234. The Surgical Company International B.V. | Paalbergweg 3 | 1105 AG Amsterdam | The Netherlands | T +31 20 7900 2100 | letsconnect@tsc-life.com www.tsc-life.com | CC no. 31029240 | VAT no. NL 8111.49.948.B03 | BANK: ING Commercial Banking | Bijlmerplein 888 | 1102 MG Amsterdam | The Netherlands IBAN NL15 INGB 0653 7522 02 | BIC: INGBNL2A Page | 3 --- **Source:** [https://fda-staging.innolitics.com/device/K261437](https://fda-staging.innolitics.com/device/K261437) **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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