Cleared Special

K133189 - DUAL SHOT ALPHA 7 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K133189 · Nemoto Kyorindo Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
256d
Days
Class 2
Risk

K133189 is an FDA 510(k) clearance for the DUAL SHOT ALPHA 7. 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 June 30, 2014 after a review of 256 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nemoto Kyorindo Co., Ltd. devices

Submission Details

510(k) Number K133189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date June 30, 2014
Days to Decision 256 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 125d · This submission: 256d
Pathway characteristics
Modification to existing cleared device.

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 206
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