Cleared Traditional

K243486 - SmartSiteTM Vented Vial Access Device (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243486 · Yukon Medical, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2024
Decision
28d
Days
Class 2
Risk

K243486 is an FDA 510(k) clearance for the SmartSiteTM Vented Vial Access Device. 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 December 6, 2024 after a review of 28 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Yukon Medical, LLC devices

Submission Details

510(k) Number K243486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2024
Decision Date December 06, 2024
Days to Decision 28 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 128d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 204
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K243486.
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K251676 · Microtek Medical, LLC · Sep 2025
HyHub™ and HyHub™ Duo Vial Access Devices
K243404 · Takeda Pharmaceuticals · Jul 2025
Arisure® Closed Male Luer with Spike Adapter (YM060)
K240761 · Yukon Medical, LLC · Mar 2025
Rio™ Drug Reconstitution Transfer Device
K243985 · Icu Medical, Inc. · Jan 2025