Cleared Traditional

K151963 - SmartSite Vented Vial Access Device

K151963 is an FDA 510(k) clearance for SmartSite Vented Vial Access Device, 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 15-day FDA review.

K151963 · Yukon Medical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
15d
Days
Class 2
Risk

K151963 is an FDA 510(k) clearance for the SmartSite 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 July 31, 2015 after a review of 15 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

FDA 510(k) Submission Details - K151963

510(k) Number K151963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2015
Decision Date July 31, 2015
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 156
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K151963.
APEX Compounding System Transfer Set
K151423 · B.Braun Medical, Inc. · Feb 2016
KIRO Set
K152441 · Kiro Robotics S.L. · Dec 2015
Universal Spike
K150787 · B.Braun Medical, Inc. · Dec 2015
VIAL-MATE Adaptor
K142600 · Baxter Healthcare Corporation · Nov 2014
VIAL2BAG DIRECT CONNECT
K140730 · Medimop Medical Projects, Ltd. · Jun 2014
MEDSOURCE SELECTABLE IV SET
K140442 · Medsource International, LLC · Apr 2014

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.