FDA Warning Letter to Unetixs Vascular, Inc. (April 15, 2026) — Premarket Approval/Adulterated

FDA Warning Letter — Violations FDA cited at Unetixs Vascular, Inc.

WARNING LETTER Unetixs Vascular, Inc. MARCS-CMS 724245 — April 15, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Mr. Neeraj Jha Recipient Title President/CEO Unetixs Vascular, Inc. 6901 TPC Drive, Suite 300 Orlando , FL 32822 United States (b)(4) Issuing Office: Center for Devices and Radiological Health United States WARNING LETTER CMS # 724245 April 15, 2026 Dear Neeraj Jha: 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