FDA cleared the Medline Reusable Blood Pressure Cuff from Medline Industries, LP on Jun 22, 2026 under K254287, a traditional 510(k). The device falls under product code DXQ, Blood Pressure Cuff, regulated at 21 CFR 870.1120 as a Class 2 device. The review panel was Cardiovascular.
FDA logged the submission as received on Dec 31, 2025. The decision came 173 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Medline Industries, LP has 5 other decisions in the tracker over the last 12 months: K253526 (NAMIC Dilator and Sheath), K253322 (Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)), K251687 (Konig Bell Circumcision Clamp), K253070 (Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)).