Cleared Traditional

K240761 - Arisure Closed Male Luer with Spike Ada...

K240761 is an FDA 510(k) clearance for Arisure Closed Male Luer with Spike Ada..., manufactured by Yukon Medical, LLC. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 366-day FDA review.

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

K240761 is an FDA 510(k) clearance for the Arisure® Closed Male Luer with Spike Adapter (YM060). Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Yukon Medical, LLC (Durham, US). The FDA issued a Cleared decision on March 21, 2025 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Yukon Medical, LLC devices

FDA 510(k) Submission Details - K240761

510(k) Number K240761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 129d · This submission: 366d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 73
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K240761.
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