Cleared Traditional

K911166 - DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 (FDA 510(k) Clearance)

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

K911166 · Diagnostic Ultrasound Corp. · Gastroenterology & Urology device
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Aug 1991
Decision
153d
Days
Class 2
Risk

K911166 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND/URO-GYN UD 511. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Diagnostic Ultrasound Corp. (Kirkland, US). The FDA issued a Cleared decision on August 15, 1991 after a review of 153 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.1650 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Ultrasound Corp. devices

Submission Details

510(k) Number K911166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1991
Decision Date August 15, 1991
Days to Decision 153 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 130d · This submission: 153d
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 206
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K911166.
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