Cleared Traditional

K122265 - VIALOK SINGLE VIAL ACCESS DEVICE VENTED

K122265 is an FDA 510(k) clearance for VIALOK SINGLE VIAL ACCESS DEVICE VENTED, 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.

K122265 · Yukon Medical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
15d
Days
Class 2
Risk

K122265 is an FDA 510(k) clearance for the VIALOK SINGLE VIAL ACCESS DEVICE VENTED. 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 August 14, 2012 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 - K122265

510(k) Number K122265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2012
Decision Date August 14, 2012
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 K122265.
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
MEDSOURCE IV ADMINSTRATION SET
K120424 · Medsource International, LLC · Jul 2012
DUAL SPIKE TRANSFER DEVICE
K120150 · B.Braun Medical, Inc. · May 2012
VIALOK NON-VENTED
K121182 · Yukon Medical, LLC · May 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.