Cleared Traditional

ADVANCE DISPOSABLE CONTROL SYRINGE (K911732) - FDA 510(k) Clearance

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

K911732 · Advance Medical Designs, Inc. · Radiology device
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Sep 1991
Decision
152d
Days
Class 2
Risk

K911732 is an FDA 510(k) clearance for the ADVANCE DISPOSABLE CONTROL SYRINGE. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on September 16, 1991 after a review of 152 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Advance Medical Designs, Inc. devices

Submission Details

510(k) Number K911732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date September 16, 1991
Days to Decision 152 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 107d · This submission: 152d
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 K911732.
AWOS ANGIOGRAPHIC WORKSTATION
K922804 · Siemens Medical Solutions USA, Inc. · Aug 1992
POLYTRON DIGITAL IMAGING SYSTEM
K920705 · Siemens Medical Solutions USA, Inc. · Apr 1992
DXS DIGITAL X-RAY SUBTRACTION
K914376 · Philips Medical Systems (Cleveland), Inc. · Feb 1992
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