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)
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.

View all Ultrasonix Medical Corpation devices

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
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 Peers - DRE Dilator, Vessel, For Percutaneous Catheterization

All 66
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K120349.
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