Cleared Traditional

K132863 - SMARTSITE VIALSHIELD

K132863 is an FDA 510(k) clearance for SMARTSITE VIALSHIELD, 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 22-day FDA review.

K132863 · Yukon Medical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
22d
Days
Class 2
Risk

K132863 is an FDA 510(k) clearance for the SMARTSITE VIALSHIELD. 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 October 4, 2013 after a review of 22 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 - K132863

510(k) Number K132863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2013
Decision Date October 04, 2013
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 129d · This submission: 22d
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 Peers - LHI Set, I.v. Fluid Transfer

All 74
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K132863.
Universal Spike
K150787 · B.Braun Medical, Inc. · Dec 2015
VIAL-MATE Adaptor
K142600 · Baxter Healthcare Corporation · Nov 2014
ADD-VANTAGE ADDAPTOR
K133602 · Hospira, Inc. · Jan 2014
DUAL SPIKE TRANSFER DEVICE
K120150 · B.Braun Medical, Inc. · May 2012
MEDLINE VIAL DECANTER
K111577 · Medline Industries, Inc. · Sep 2011
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
K100640 · B.Braun Medical, Inc. · Jul 2010