Cleared Traditional

FEMORAL ANGIOGRAPHY DRAPE (K896088) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896088 · Medical Plastics, Inc. · Radiology device
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Nov 1989
Decision
29d
Days
Class 2
Risk

K896088 is an FDA 510(k) clearance for the FEMORAL ANGIOGRAPHY DRAPE. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Medical Plastics, Inc. (Roswell, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - the FDA radiology and imaging software 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 Medical Plastics, Inc. devices

Submission Details

510(k) Number K896088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1989
Decision Date November 17, 1989
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 Radiology devices follow this clearance model.

Regulatory Peers - IZI System, X-ray, Angiographic

All 49
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K896088.
POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM
K913120 · Siemens Medical Solutions USA, Inc. · Aug 1991
ADVANTX AFM ANGIO SYSTEM S1808
K905653 · GE Medical Systems · May 1991
ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)
K897115 · Toshiba America Medical Systems, In.C · Mar 1990
LC, CARDIAC POSITIONER #B5078A
K890348 · General Electric Co. · Feb 1989
MULTISKOP
K890352 · Siemens Medical Solutions USA, Inc. · Feb 1989
ANGIOSTAR
K884912 · Siemens Medical Solutions USA, Inc. · Feb 1989