Unetixs Vascular, Inc.

During an inspection of your firm, Unetixs Vascular, Inc., located in Warwick, RI from September 19, 2025, through December 4, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures vascular diagnostic ultrasound systems, including the ROODRA and 2CP devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

Our inspection revealed that the MultiLab Series ROODRA and 2CP vascular diagnostic devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device with its current modifications into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Specifically, the modified MultiLab Series ROODRA and 2CP vascular diagnostic devices that you are distributing do not have 510(k) clearance. While MultiLab Series ROODRA and 2CP vascular diagnostic devices have a prior 510(k) clearance (K904392), the modified devices include both design and labeling modifications – as documented in your firm’s “Regulatory Change Assessment - ENGINEERING CHANGE RECORD ECR # 0137 - Changing all applicable items from luer connections to bayonet connections” – which could significantly affect the safety and effectiveness of the device and, under 21 CFR 807.81(a)(3)(i), require a new 510(k) submission. Our review found that the change was implemented to significantly mitigate a known risk in response to an adverse event. Specifically, the device design, construction materials and labeling changes, to physically prevent device misconnections, were implemented to address a complaint of a death caused by air embolism.

We also remind you on February 4, 2020, a Warning Letter, CMS Case #598016, was issued to you for significant quality system violations related to your vascular diagnostic ultrasound systems. We understand that while you have made progress in implementing corrective actions, deficiencies remain as documented during the recent inspection. You should continue to ensure that you are making further progress to be in compliance with all of our regulations. On February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. Your most recent inspection on September 19, 2025, through December 4, 2025, was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, any corrective actions you propose or implement must be pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage: Quality Management System Regulation – Frequently Asked Questions. The 2020 Warning Letter will remain open until we verify that you have successfully implemented all necessary corrections.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Gina Brackett, Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case # 724245” when replying. If you have any questions about the contents of this letter, please contact: Karen Archdeacon at karen.archdeacon@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.