Cleared Traditional

K001663 - FRONT-LOAD POLYPROPYLENE SYRINGE

K001663 is an FDA 510(k) clearance for FRONT-LOAD POLYPROPYLENE SYRINGE, manufactured by Medrad, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K001663 · Medrad, Inc. · Cardiovascular device
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Nov 2000
Decision
169d
Days
Class 2
Risk

K001663 is an FDA 510(k) clearance for the FRONT-LOAD POLYPROPYLENE SYRINGE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on November 16, 2000 after a review of 169 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 Medrad, Inc. devices

FDA 510(k) Submission Details - K001663

510(k) Number K001663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2000
Decision Date November 16, 2000
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
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 169
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K001663.
MONARCH INFLATION SYRINGE
K011811 · Merit Medical Systems, Inc. · Aug 2001
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
K011991 · Medrad, Inc. · Aug 2001
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
K010390 · Acist Medical Systems, Inc. · Mar 2001
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
K984231 · Invasatec · May 2000
MODIFICATION TO ACIST CL 100H
K991103 · Acist Medical Systems · May 2000
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
K983826 · Unimachs Corp. · Mar 2000