Cleared Traditional

K983826 - 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM

K983826 is an FDA 510(k) clearance for 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM, manufactured by Unimachs Corp.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 511-day FDA review.

K983826 · Unimachs Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2000
Decision
511d
Days
Class 2
Risk

K983826 is an FDA 510(k) clearance for the 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Unimachs Corp. (Bethesda, US). The FDA issued a Cleared decision on March 23, 2000 after a review of 511 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 Unimachs Corp. devices

FDA 510(k) Submission Details - K983826

510(k) Number K983826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1998
Decision Date March 23, 2000
Days to Decision 511 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
386d slower than avg
Panel avg: 125d · This submission: 511d
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 128
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K983826.
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
K010390 · Acist Medical Systems, Inc. · Mar 2001
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · Medrad, Inc. · Nov 2000
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
K984231 · Invasatec · May 2000
OPTISTAR MR INJECTOR SYSTEM
K984088 · Mallinckrodt Inc., Liebel-Flarsheim Business · Dec 1999
MEDRAD ENVISION CT INJECTOR SYSTEM
K993728 · Medrad, Inc. · Nov 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K991557 · Medrad, Inc. · Jul 1999