Cleared Traditional

REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS (K092896) - FDA 510(k) Clearance

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

K092896 · Nemoto Kyorindo Co., Ltd. · Cardiovascular device
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Oct 2010
Decision
403d
Days
Class 2
Risk

K092896 is an FDA 510(k) clearance for the REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Nemoto Kyorindo Co., Ltd. (Kawaguchi-Shi, Saitama, JP). The FDA issued a Cleared decision on October 29, 2010 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Nemoto Kyorindo Co., Ltd. devices

Submission Details

510(k) Number K092896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2009
Decision Date October 29, 2010
Days to Decision 403 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
278d slower than avg
Panel avg: 125d · This submission: 403d
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 49
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K092896.
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