Cleared Traditional

K960430 - CONTROL SYRINGE

K960430 is an FDA 510(k) clearance for CONTROL SYRINGE, manufactured by Scientific Device Manufacturer, LLC. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K960430 · Scientific Device Manufacturer, LLC · Cardiovascular device
Download Printable Device Report (PDF)
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Aug 1996
Decision
188d
Days
Class 2
Risk

K960430 is an FDA 510(k) clearance for the CONTROL SYRINGE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Scientific Device Manufacturer, LLC (San Rafael, US). The FDA issued a Cleared decision on August 6, 1996 after a review of 188 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. 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 Scientific Device Manufacturer, LLC devices

FDA 510(k) Submission Details - K960430

510(k) Number K960430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1996
Decision Date August 06, 1996
Days to Decision 188 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 125d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 145
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K960430.
RNS STERILE, DISPOSABLE CT BIOPSY TRAY
K955685 · Contour Fabricators of Florida, Inc. · Oct 1996
CONTRAST INJECTION LINES
K960674 · B.Braun Medical, Inc. · Sep 1996
FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
K960965 · Coeur Laboratories, Inc. · Sep 1996
RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
K955684 · Contour Fabricators of Florida, Inc. · May 1996
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT
K955381 · B.Braun Medical, Inc. · Feb 1996
MEDRAD SPECTRIS MR INJECTOR
K935668 · Medrad, Inc. · Sep 1995