Cleared Traditional

K955684 - RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY (FDA 510(k) Clearance)

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

K955684 · Contour Fabricators of Florida, Inc. · Cardiovascular device
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May 1996
Decision
140d
Days
Class 2
Risk

K955684 is an FDA 510(k) clearance for the RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Contour Fabricators of Florida, Inc. (Palm Harobor, US). The FDA issued a Cleared decision on May 2, 1996 after a review of 140 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 Contour Fabricators of Florida, Inc. devices

Submission Details

510(k) Number K955684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 14, 1995
Decision Date May 02, 1996
Days to Decision 140 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 125d · This submission: 140d
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 206
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K955684.
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High Pressure Tubing
K244038 · Shandong Int Medical Instruments Co., Ltd. · Sep 2025
Angiography Injector
K242143 · Shandong Int Medical Instruments Co., Ltd. · Dec 2024
Disposable Syringe (Kit)
K242212 · Nemoto Kyorindo Co., Ltd. · Aug 2024