Cleared Traditional

Arisure? Closed Male Luer with Spike Adapter (YM060)

K240761 · Yukon Medical, LLC · General Hospital
Mar 2025
Decision
366d
Days
Class 2
Risk

About This 510(k) Submission

K240761 is an FDA 510(k) clearance for the Arisure? Closed Male Luer with Spike Adapter (YM060), a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Yukon Medical, LLC (Durham, US). The FDA issued a Cleared decision on March 21, 2025, 366 days after receiving the submission on March 20, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K240761 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2024
Decision Date March 21, 2025
Days to Decision 366 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LHI — Set, I.v. Fluid Transfer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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