Cleared Traditional

TRANSDUCER PROTECTOR (K915593) - FDA 510(k) Clearance

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

K915593 · United Pharmaceutical and Medical Supply Co. · Gastroenterology & Urology device
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Jul 1992
Decision
201d
Days
Class 2
Risk

K915593 is an FDA 510(k) clearance for the TRANSDUCER PROTECTOR. Classified as Protector, Transducer, Dialysis (product code FIB), Class II - Special Controls.

Submitted by United Pharmaceutical and Medical Supply Co. (Berkeley, US). The FDA issued a Cleared decision on July 1, 1992 after a review of 201 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 United Pharmaceutical and Medical Supply Co. devices

Submission Details

510(k) Number K915593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1991
Decision Date July 01, 1992
Days to Decision 201 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 130d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIB Protector, Transducer, Dialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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.