510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K120349Substantially Equivalent

Sonixgps Vascular Access Needle Kit

Ultrasonix Medical Corpation, Richmond, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120349 is the FDA 510(k) clearance record for SONIXGPS VASCULAR ACCESS NEEDLE KIT, a class II device, cleared for Ultrasonix Medical Corpation on under FDA product code DRE (Dilator, Vessel, For Percutaneous Catheterization). FDA records list one 510(k) clearance for Ultrasonix Medical Corpation. As of , FDA records show no recalls naming K120349.

Clearance record

Decision date
Received
(63 days to decision)
Product code
DRE Dilator, Vessel, For Percutaneous Catheterization
Regulation
21 CFR 870.1310
Device class
Class II
Review panel
Cardiovascular
Applicant
Ultrasonix Medical Corpation 130-4311 Viking Way, Richmond, CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DRE

Trailing 12 months
2 clearances under product code DRE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260