Cleared Traditional

K120349 - SONIXGPS VASCULAR ACCESS NEEDLE KIT

K120349 is an FDA 510(k) clearance for SONIXGPS VASCULAR ACCESS NEEDLE KIT, manufactured by Ultrasonix Medical Corpation. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K120349 · Ultrasonix Medical Corpation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
63d
Days
Class 2
Risk

K120349 is an FDA 510(k) clearance for the SONIXGPS VASCULAR ACCESS NEEDLE KIT. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Ultrasonix Medical Corpation (Richmond, CA). The FDA issued a Cleared decision on April 9, 2012 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - the FDA cardiovascular device oversight 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.

FDA 510(k) Submission Details - K120349

510(k) Number K120349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date April 09, 2012
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Intertek Testing Services
WILLIAM SAMMONS

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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 96
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K120349.
LAWMAX DILATOR
K123842 · Lifetech Scientific (Shenzhen) Co., Ltd. · Jun 2013
PRELUDE SHEATH INTRODUCER
K130791 · Merit Medical Systems, Inc. · Jun 2013
NMI COAXIAL MICROINTRODUCER SET
K123445 · Navilyst Medical, Inc. · Apr 2013
ARSTASIS DILATOR ADAPTER
K103421 · Arstasis, Inc. · May 2011
RETROFLEX DILATOR KIT
K093554 · Edwards Lifesciences, LLC · Apr 2010
SPECTRANETICS VISISHEATH DILATOR SHEATH
K092378 · Spectranetics Corp. · Nov 2009
K120349 · SONIXGPS VASCULAR ACCESS NEEDLE KIT
Download PDF FDA Summary Ultrasonix Medical Co…