Cleared Traditional

K915593 - TRANSDUCER PROTECTOR

K915593 is an FDA 510(k) clearance for TRANSDUCER PROTECTOR, manufactured by United Pharmaceutical and Medical Supply Co.. The device is a Class 2 Gastroenterology & Urology device with product code FIB cleared through the Traditional 510(k) pathway after a 201-day FDA review.

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

FDA 510(k) Submission Details - K915593

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.

FIB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FIB Protector, Transducer, Dialysis

All 13
Devices cleared under the same product code (FIB) and FDA review panel - the closest regulatory comparables to K915593.
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
K003445 · Fresenius Medical Care North America · Dec 2000
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
K000702 · Fresenius Medical Care North America · Jun 2000
MILLEX, DUALEX (PLUS, ULTRA)
K934069 · Millipore Corp. · Apr 1994
TRANSDUCER PROTECTOR
K910821 · Gelman Sciences, Inc. · Aug 1991
DA-46 FLUID BARRIER
K891752 · Akcess Medical Products, Inc. · Apr 1989
GAMBRO PRESSURE MONITOR GUARDS
K851230 · Gambro, Inc. · Apr 1985