Cleared Traditional

K984088 - OPTISTAR MR INJECTOR SYSTEM

K984088 is an FDA 510(k) clearance for OPTISTAR MR INJECTOR SYSTEM, manufactured by Mallinckrodt Inc., Liebel-Flarsheim Business. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K984088 · Mallinckrodt Inc., Liebel-Flarsheim Business · Cardiovascular device
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Dec 1999
Decision
385d
Days
Class 2
Risk

K984088 is an FDA 510(k) clearance for the OPTISTAR MR INJECTOR SYSTEM. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Mallinckrodt Inc., Liebel-Flarsheim Business (Cincinnati, US). The FDA issued a Cleared decision on December 6, 1999 after a review of 385 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Mallinckrodt Inc., Liebel-Flarsheim Business devices

FDA 510(k) Submission Details - K984088

510(k) Number K984088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date December 06, 1999
Days to Decision 385 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
260d slower than avg
Panel avg: 125d · This submission: 385d
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 K984088.
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · Medrad, Inc. · Nov 2000
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
K984231 · Invasatec · May 2000
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
K983826 · Unimachs Corp. · Mar 2000
MEDRAD ENVISION CT INJECTOR SYSTEM
K993728 · Medrad, Inc. · Nov 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K991557 · Medrad, Inc. · Jul 1999
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
K984418 · Medrad, Inc. · Mar 1999