Cleared Traditional

PRESS DUO elite, PRESS DUO elite AG (K173450) - FDA 510(k) Clearance

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

K173450 · Nemoto Kyorindo Co., Ltd. · Cardiovascular device
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Feb 2018
Decision
93d
Days
Class 2
Risk

K173450 is an FDA 510(k) clearance for the PRESS DUO elite, PRESS DUO elite AG. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Nemoto Kyorindo Co., Ltd. (Bunkyo-Ku, JP). The FDA issued a Cleared decision on February 7, 2018 after a review of 93 days - within the typical 510(k) review window.

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 Nemoto Kyorindo Co., Ltd. devices

Submission Details

510(k) Number K173450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2017
Decision Date February 07, 2018
Days to Decision 93 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
32d faster than avg
Panel avg: 125d · This submission: 93d
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 48
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K173450.
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
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ACISTCVi® Contrast Delivery System
K171646 · Acist Medical Systems, Inc. · Feb 2018
Merit Coronary Control Syringe
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DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107 · Merit Medical Systems, Inc. · Jul 2016
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
K093830 · Medline Industries, Inc. · Mar 2011