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
Combination Product No
PCCP Authorized No
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 Consultant

Ultra Life Science Solutions, Inc.
CHRISTINA HENZA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 178
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K162088.
Merit Coronary Control Syringe
K163084 · Merit Medical Systems, Inc. · Jun 2017
DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
K171217 · Osprey Medical, Inc. · May 2017
DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
K163054 · Osprey Medical, Inc. · Mar 2017
Disposable High Pressure Injector Syringe
K152906 · Wuxi Yushou Medical Appliances Co., Ltd. · Nov 2016
Sunmed Control Syringes
K160190 · Sunny Medical Device (Shenzhen) Co., Ltd. · Nov 2016
MR Syringe Dual Pack for Solaris Injectors
K161471 · Coeur, Inc. · Oct 2016