Cleared Traditional

K052633 - DUAL SHOT - CONTRAST DELIVERY SYSTEM

K052633 is an FDA 510(k) clearance for DUAL SHOT - CONTRAST DELIVERY SYSTEM, 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 21-day FDA review.

K052633 · Nemoto Kyorindo Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
21d
Days
Class 2
Risk

K052633 is an FDA 510(k) clearance for the DUAL SHOT - CONTRAST DELIVERY SYSTEM. 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 October 17, 2005 after a review of 21 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 - K052633

510(k) Number K052633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2005
Decision Date October 17, 2005
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
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 Peers - DXT Injector And Syringe, Angiographic

All 111
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