Cleared Traditional

K902692 - DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002

K902692 is an FDA 510(k) clearance for DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002, manufactured by Diagnostic Ultrasound Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K902692 · Diagnostic Ultrasound Corp. · Gastroenterology & Urology device
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Sep 1990
Decision
86d
Days
Class 2
Risk

K902692 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Diagnostic Ultrasound Corp. (Kirkland, US). The FDA issued a Cleared decision on September 13, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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: 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 Diagnostic Ultrasound Corp. devices

FDA 510(k) Submission Details - K902692

510(k) Number K902692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1990
Decision Date September 13, 1990
Days to Decision 86 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
44d faster than avg
Panel avg: 130d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 25
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K902692.
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