Cleared Traditional

K131478 - CONTRAST CONSERVATION SYSTEM

K131478 is the FDA 510(k) clearance for CONTRAST CONSERVATION SYSTEM by Osprey Medical, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K131478 · Osprey Medical, Inc. · Cardiovascular device
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Aug 2013
Decision
85d
Days
Class 2
Risk

K131478 is an FDA 510(k) clearance for the CONTRAST CONSERVATION SYSTEM. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Osprey Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 15, 2013 after a review of 85 days - a notably fast clearance 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: 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 Osprey Medical, Inc. devices

Submission Details

510(k) Number K131478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2013
Decision Date August 15, 2013
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 102
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K131478.
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MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
K113133 · Medrad, Inc. · Dec 2011
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
K113198 · Navilyst Medical, Inc. · Nov 2011
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
K112086 · Medrad, Inc. · Oct 2011