Cleared Traditional

K051655 - ANGIODYNAMICS

K051655 is the FDA 510(k) clearance for ANGIODYNAMICS by AngioDynamics, Inc.. It is a Class 2 Cardiovascular device (product code DQR) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K051655 · AngioDynamics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
83d
Days
Class 2
Risk

K051655 is an FDA 510(k) clearance for the ANGIODYNAMICS, INC., MICRO ACCESS KITS. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on September 12, 2005 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1300 - 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 AngioDynamics, Inc. devices

Submission Details

510(k) Number K051655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2005
Decision Date September 12, 2005
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQR Cannula, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1300
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 - DQR Cannula, Catheter

All 13
Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K051655.
INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
K131446 · Integra LifeSciences Corporation · Oct 2013
RMI INTERNAL MAMMARY ARTERY CANNULA
K960098 · Research Medical, Inc. · Mar 1996
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
K902674 · Datascope Corp. · Jan 1991
MODIFIED SHILEY FEMORAL VENOUS CANNULA
K894784 · Shiley, Inc. · Mar 1990
RMI ARTERIAL PERFUSION CANNULA
K894243 · Research Medical, Inc. · Sep 1989
DAIG COLLAPSIBLE STERILE SLEEVE
K884478 · Daig Corp. · Feb 1989