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
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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
Combination Product No
PCCP Authorized No
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 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 K132863.
E-Z LINK
K133097 · Duoject Medical Systems, Inc. · Mar 2014
ADD-VANTAGE ADDAPTOR
K133602 · Hospira, Inc. · Jan 2014
DISPOSABLE INFUSION SET
K131646 · Shanghai Jinta Medical Co., Ltd. · Nov 2013
MP VIAL ADAPTER 13MM
K130179 · Medimop Medical Projects, Ltd. · Aug 2013
VIAL CONNECTOR 13MM CLOSED COLLAR
K132040 · Medimop Medical Projects, Ltd. · Jul 2013
PROTECTOR, INJECTOR, CONNECTOR
K120384 · Bd Medical-Medical Surgical Systems · Sep 2012

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.