Cleared Traditional

BLADDERMANAGER PCI 5000 MODEL 1002 (K982568) - FDA 510(k) Clearance

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

K982568 · Diagnostic Ultrasound Corp. · Radiology device
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Jan 1999
Decision
186d
Days
Class 2
Risk

K982568 is an FDA 510(k) clearance for the BLADDERMANAGER PCI 5000 MODEL 1002. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Diagnostic Ultrasound Corp. (Redmond, US). The FDA issued a Cleared decision on January 25, 1999 after a review of 186 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Diagnostic Ultrasound Corp. devices

Submission Details

510(k) Number K982568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1998
Decision Date January 25, 1999
Days to Decision 186 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 107d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 75
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