Cleared Traditional

K991103 - MODIFICATION TO ACIST CL 100H

K991103 is an FDA 510(k) clearance for MODIFICATION TO ACIST CL 100H, manufactured by Acist Medical Systems. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 426-day FDA review.

K991103 · Acist Medical Systems · Cardiovascular device
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May 2000
Decision
426d
Days
Class 2
Risk

K991103 is an FDA 510(k) clearance for the MODIFICATION TO ACIST CL 100H. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Acist Medical Systems (Eden Prairie, US). The FDA issued a Cleared decision on May 31, 2000 after a review of 426 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 Acist Medical Systems devices

FDA 510(k) Submission Details - K991103

510(k) Number K991103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date May 31, 2000
Days to Decision 426 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
301d slower than avg
Panel avg: 125d · This submission: 426d
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 121
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K991103.
MONARCH INFLATION SYRINGE
K011811 · Merit Medical Systems, Inc. · Aug 2001
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
K011991 · Medrad, Inc. · Aug 2001
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · Medrad, Inc. · Nov 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