Skytron, LLC

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, which is different than medical washer-disinfector devices identified in 21 CFR 880.6992 under which you registered the device.

For example, we reviewed your website on May 11, 2026 and it includes the following statements:

Regarding the 1140 Sentry, 2280 Syndicate, and 3200 Max:

“More Effective Disinfections - 5 Log Reduction Rate - Fewer Germs and Bacteria”

“Whole-Room Disinfections - Includes shadowed surfaces - Disinfects all room surfaces”

“Infection Prevention Technologies has the ideal UVC solution to fill the disinfection needs of any facility and budget. Industries we serve… Hospitals Serviced by Skytron”

Regarding the UV Smart D25:

“Achieves at least a log-4 reduction in the full spectrum of microorganisms”

“FDA registered UVC device, ensures disinfection of non-invasive medical equipment”

“Examples of Equipment that can be Disinfected - Infusion Pumps - Thermometers - Stethoscopes - Surveillance Monitoring Equipment - Blood Pressure Pumps - Pulse Oximeters - Telemetry Equipment - Glucose Meters…”

“UV Smart, countertop rapid UVC Disinfector keep germs and viruses away from patients.”

In addition, your UV Smart D25 Countertop UVC Disinfector brochure, UV-Smart-D25-Brochure-WEB.pdf, includes the following statements:

“The UV Smart D25 disinfection system is the first FDA registered UVC device used to clean non-invasive medical equipment. The disinfection efficacy of the UV Smart D25 has been demonstrated and supported by numerous comprehensive studies conducted in clinical settings at academic medical centers and laboratories...”

“Achieve ultimate UVC disinfection of your smaller medical belongings in less than 30 seconds. The UV Smart D25 is a simple-to-use solution to disinfect your hard to clean high-touch items like IV pumps, enteral feeding pumps, monitoring equipment, and thermometers...”

“Advantages offered by the UV Smart D25• Automated and consistent disinfection cycle in less than 30 seconds saving working time• Validated, certified and supported by clinical research• Acts on full spectrum of resistant infection-causing microbes• Achieves at least a log-4 reduction in the full spectrum of microorganisms• FDA registered UVC device, ensures disinfection of non-invasive medical equipment…”

“Examples of Equipment that can be Disinfected• Infusion Pumps• Thermometers• Stethoscopes• Surveillance Monitoring Equipment• Blood Pressure Pumps• Pulse Oximeters• Telemetry Equipment• Glucose Meters• Reflex Hammers• Comedone Expressors…”

The brochure includes a table entitled, “UV Smart D25 Microbiological Efficacy Chart,” which purports to compare medically required reduction of particular microorganisms with the reduction accomplished through use of your device.

Your firm has provided no evidence to FDA supporting the safety and effectiveness of these devices for use in disinfecting healthcare environments and/or medical device equipment, as applicable, for the protection of patients against infection or infection causing microbes. FDA is currently unaware of any literature that could support your claims regarding your devices’ functionality for these intended uses. The lack of evidence demonstrating the safety and effectiveness of these devices raise concerns related to potential harm to healthcare workers and patients following UV radiation or chemical byproduct exposure, including skin, eye, and respiratory damage, as well as the risk of patient cross-contamination resulting from inadequate microbial reduction due to device failure or insufficient microbicidal performance. Furthermore, there is a risk that UV radiation emitted by the device may compromise the material integrity of other semi-critical or critical devices in the space, potentially affecting their safety and performance.

Correspondence with Skytron since February 2022, as described below, reflects ongoing FDA concern about Skytron’s marketing of the above-named devices.

We informed you on February 12, 2022, via an It Has Come to Our Attention (IHCTOA) letter that it appeared that you were marketing your 1140 Sentry Single Emitter System, 3200 Max Single Emitter System, 2280 Syndicate Dual Emitter System, and UV Smart Countertop Rapid UVC Disinfector devices, in a manner that potentially violated the Act. You acknowledged receipt of the letter on February 14, 2022, and replied on April 1, 2022 and June 9, 2022, informing FDA of your intention to limit the statements to those relevant to environmental treatment not typically subject to FDA premarket review. A follow-up e-mail was sent to you on February 26, 2024, after a review of your website found statements showing that your devices were indicated for use in improving the terminal cleaning process for healthcare facilities, and pictures of these devices being used in healthcare spaces. You replied on March 4, 2024, informing us of your decision to remove any claims or images related to healthcare use. That email contained the following: “We’ve made the decision to remove any claims or images related to healthcare use of our 1140 Sentry Single Emitter System, 3200 Max Single Emitter System and 2280 Syndicate Dual Emitter System. This process should be finished within six months. I’ll update the group once this task is done. Feel free to reach out if you have any concerns in the meantime.”

On July 1, 2024, we informed you that your website continues to include statements indicating that your 1140 Sentry Single Emitter System, 3200 Max Single Emitter System, and 2280 Syndicate Dual Emitter System products are intended for disease mitigation, disease prevention, risk reduction, health improvement and similar or related statements, including text, images and videos showing the use of your device in healthcare-related environments and for the decontamination of medical devices. We requested that you either remove these claims or submit a formal letter via e-mail by July 9, 2024, indicating that you planned to submit a 510(k) premarket notification by no later than July 31, 2024. You responded on July 5, 2024, stating that your website was updated to address FDA concerns. That email stated, “We have updated our website and removed the text, images, and videos as referenced in your email. Please review these changes and let us know of any further concerns.”

However, as noted, as of May 11, 2026, your firm’s website, as well as other current marketing materials, include statements inconsistent with your July 5, 2024, statement to FDA regarding addressing the agency’s concerns. Your materials continue to promote your devices for unapproved medical uses in violation of the Act after you responded to the IHCTOA letter and interactive e-mails indicating that you were going to remove the healthcare use claims for these devices from your webpage.

For medical devices requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency in accordance with 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 https://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.

Our office requests that you cease any activities that result in the misbranding or adulteration of the 1140 Sentry, 2280 Syndicate, 3200 Max, and UV Smart D25 devices, such as the commercial distribution of the devices for the uses discussed above.

Your firm should take prompt action to address any violations identified in this letter. Failure to promptly and 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 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 correct the noted violation, as well as an explanation of how your firm plans to prevent the violation, or similar violation, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) 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 all violations included in this Warning Letter. If you believe that your products are not in violation of the Act, please include your reasoning and any supporting information for our consideration as part of your response.

Your firm's response should be sent to via email to Christopher Dugard at CDRHEnforcement@fda.hhs.gov. Please include 'CPT2401217’ in the subject line when replying. If you have any questions about the contents of this letter, please contact Stephen Anisko at stephen.anisko@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. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.