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After consideration of the public comment we received and our review of the application, we have determined that the SCOUT MD TM Delivery System meets the device category criterion at 419.66(c)(2)

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"Your firms corrective actions only included scrapping devices in inventory and increasing the cleaning frequency of the [redacted] machine to prevent excess silicone from migrating to the luer connector, despite receiving 221 complaints and filing 177 [medical device reports (MDR)] for the disconnection of the NAMIC Angiographic Control Syringes from manifolds which impact patients and clinicians, including one (1) MDR # 3015910259-2025-00109 involving the injection of air into a patient (Complaint # [redacted] dated [redacted]) and one (1) MDR # 3015910259-2024-00045 involving biohazard exposure of a clinician (Complaint # [redacted] dated [redacted])." Furthermore, Medline Industries was cited for other violations, including failing to maintain schedules for adjusting, cleaning, and performing other equipment maintenance to ensure compliance with manufacturing specifications