Cleared Traditional

K875324 - MODIFIED SCHNEIDER SHILEY INFLATION SYR...

K875324 is the FDA 510(k) clearance for MODIFIED SCHNEIDER SHILEY INFLATION SYR... by Schneider-Shilley (Usa). It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K875324 · Schneider-Shilley (Usa) · Cardiovascular device
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Mar 1988
Decision
87d
Days
Class 2
Risk

K875324 is an FDA 510(k) clearance for the MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Schneider-Shilley (Usa) (Minneapolis, US). The FDA issued a Cleared decision on March 25, 1988 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Schneider-Shilley (Usa) devices

Submission Details

510(k) Number K875324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1987
Decision Date March 25, 1988
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 102
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K875324.
ACS INDEFLATOR P/T 20
K883452 · Advanced Cardiovascular Systems, Inc. · Oct 1988
MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
K880493 · Medrad, Inc. · Apr 1988
ANGIO DRAPE PACK ACP-010FM
K880310 · Arrow Intl., Inc. · Apr 1988
DISPOSABLE CORONARY CONTROL SYRINGE 12CC
K875196 · Merit Medical Systems, Inc. · Feb 1988
MEDRAD MRI INJECTION SYSTEM
K873173 · Medrad, Inc. · Feb 1988
ACS INDEFLATOR PLUS (MODIFICATION #2)
K872981 · Advanced Cardiovascular Systems, Inc. · Oct 1987