Cleared Traditional

Ecomed Disposable Angiographic Syringes (K162088) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 49
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
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
K093830 · Medline Industries, Inc. · Mar 2011
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523 · Merit Medical Systems, Inc. · Feb 2009