Cleared Traditional

DeRoyal Angiography Kits (K152978) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152978 · Deroyal Industries, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2016
Decision
168d
Days
Class 2
Risk

K152978 is an FDA 510(k) clearance for the DeRoyal Angiography Kits. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on March 25, 2016 after a review of 168 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Deroyal Industries, Inc. devices

Submission Details

510(k) Number K152978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 09, 2015
Decision Date March 25, 2016
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 45
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K152978.
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MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
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MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523 · Merit Medical Systems, Inc. · Feb 2009
MONARCH INFLATION SYRINGE
K011811 · Merit Medical Systems, Inc. · Aug 2001