Cleared Traditional

K162088 - Ecomed Disposable Angiographic Syringes

K162088 is an FDA 510(k) clearance for Ecomed Disposable Angiographic Syringes, manufactured by Ecomed Solutions, LLC. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K162088 · Ecomed Solutions, LLC · Cardiovascular device
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Jan 2017
Decision
183d
Days
Class 2
Risk

K162088 is an FDA 510(k) clearance for the Ecomed Disposable Angiographic Syringes. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Ecomed Solutions, LLC (Mundelein, US). The FDA issued a Cleared decision on January 27, 2017 after a review of 183 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 Ecomed Solutions, LLC devices

FDA 510(k) Submission Details - K162088

510(k) Number K162088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2016
Decision Date January 27, 2017
Days to Decision 183 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
58d slower than avg
Panel avg: 125d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

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 111
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K162088.
ACISTCVi® Contrast Delivery System
K171646 · Acist Medical Systems, Inc. · Feb 2018
PRESS DUO elite, PRESS DUO elite AG
K173450 · Nemoto Kyorindo Co., Ltd. · Feb 2018
Merit Coronary Control Syringe
K163084 · Merit Medical Systems, Inc. · Jun 2017
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107 · Merit Medical Systems, Inc. · Jul 2016
DeRoyal Angiography Kits
K152978 · Deroyal Industries, Inc. · Mar 2016
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
K113133 · Medrad, Inc. · Dec 2011