Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) (K253070): 510(k) cleared Nov 20, 2025

Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)

Medline Industries, LP · Nov 20, 2025 · K253070

FDA cleared the Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) from Medline Industries, LP on Nov 20, 2025 under K253070, a traditional 510(k). The device falls under product code DXC, Clamp, Vascular, regulated at 21 CFR 870.4450 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 23, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

Medline Industries, LP has 5 other decisions in the tracker over the last 12 months: K253526 (NAMIC Dilator and Sheath), K254287 (Medline Reusable Blood Pressure Cuff), 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).

Questions & Answers

What did FDA clear under K253070?

K253070 is the FDA 510(k) for Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL), submitted by Medline Industries, LP. FDA's decision date was Nov 20, 2025, under product code DXC (Clamp, Vascular).

Who makes the Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)?

Medline Industries, LP, based in Northfiled, IL, is the applicant of record for K253070.

How long did the K253070 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Nov 20, 2025, 58 days later.

← All decisions in November 2025