Skytron, LLC — FDA Warning Letter, May 19, 2026: Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

FDA Warning Letter — Violations FDA cited at Skytron, LLC

WARNING LETTER Skytron, LLC MARCS-CMS 723950 — May 19, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name David Mehney Recipient Title CEO Skytron, LLC 5085 Corporate Exchange Blvd SE Grand Rapids , MI 49512 United States (b)(6)@Skytron.com Issuing Office: Center for Devices and Radiological Health United States WARNING LETTER May 19, 2026 Dear David Mehney, The United States Food and Drug Administration (FDA or agency) has learned that your firm is marketing the 1140 Sentry, 2280 Syndicate, 3200 Max and UV Smart D25 in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of 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. FDA has reviewed your firm’s webpages at https://www.skytron.com/infection-prevention-technologies/, https://www.skytron.com/wp-content/uploads/documentation/UVC-Correctional-Disinfection-REV3-WEB.pdf and UV-Smart-D25-Brochure-WEB.pdf and has determined that the 1140 Sentry, 2280 Syndicate, 3200 Max, and UV Smart D25 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the devices as described and marketed. The 1140 Sentry, 2280 Syndicate, 3200 Max, and UV Smart D25 devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81. The UV Smart D25 device is further misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a) because of your misleading references, identified in the quoted statements below, to your firm’s registration. Your brochure for that device references that product’s FDA registration in the context of “use[] to clean non-invasive medical equipment,” which creates an impression of official FDA approval, clearance, authorization, or endorsement or other evaluation of your products that is misleading and constitutes misbranding. See 21 CFR 807.39. In addition, although there is a 510(k) exemption for medical washer-disinfector devices under 21 CFR 880.6992, which is the regulation (and product code MEC) under which you registered the UV Smart D25 device, the device is not exempt because it is not the type of device that is within the generic category of devices identified under § 880.6992. Generic devices of this type include functional steps that utilize mechanical processes to physically remove contamination from devices followed by a separate disinfection step, which can be either thermal or chemical. However, based on evidence obtained from your website, the UV Smart D25 is described as utilizing UVC to “clean non-invasive medical equipment.” However, we note that the device does not include a mechanical cleaning step, and disinfection is achieved utilizing non-ionizing UV-C radiation, with no mechanical action included. FDA has defined “cleaning” in this context as “the physical removal of soil and contaminants from an item”. 1 In addition, FDA does not consider non-ionizing radiation to fall within the scope of “thermal or chemical” disinfection. As a result, the device fails to qualify for 510(k) exemption under 21 CFR 880.6992 because the device’s technology includes neither a mechanical cleaning nor disinfection step, wh