Cleared Traditional

K062168 - CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA

K062168 is an FDA 510(k) clearance for CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA, manufactured by Nemoto Kyorindo Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K062168 · Nemoto Kyorindo Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
18d
Days
Class 2
Risk

K062168 is an FDA 510(k) clearance for the CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Nemoto Kyorindo Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on August 18, 2006 after a review of 18 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 Nemoto Kyorindo Co., Ltd. devices

FDA 510(k) Submission Details - K062168

510(k) Number K062168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2006
Decision Date August 18, 2006
Days to Decision 18 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

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 177
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K062168.
DUAL SHOT ALPHA
K071691 · Nemoto Kyorindo Co., Ltd. · Dec 2007
ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS
K070798 · Coeur, Inc. · Oct 2007
CKIS-004A INJECTOR SYNCHRONIZATION OPTION
K061976 · Toshiba America Medical Systems, In.C · Sep 2006
C2000 AUTOMATED MANIFOLD KIT
K052744 · Acist Medical Systems, Inc. · Dec 2005
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
K051799 · Coeur, Inc. · Nov 2005
DUAL SHOT - CONTRAST DELIVERY SYSTEM
K052633 · Nemoto Kyorindo Co., Ltd. · Oct 2005