Cleared Traditional

K904912 - TRANSDUCER PROTECTOR

K904912 is an FDA 510(k) clearance for TRANSDUCER PROTECTOR, manufactured by Filtertek, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIB cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K904912 · Filtertek, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1991
Decision
65d
Days
Class 2
Risk

K904912 is an FDA 510(k) clearance for the TRANSDUCER PROTECTOR. Classified as Protector, Transducer, Dialysis (product code FIB), Class II - Special Controls.

Submitted by Filtertek, Inc. (Hebron, US). The FDA issued a Cleared decision on January 4, 1991 after a review of 65 days - a notably fast clearance 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: 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 Filtertek, Inc. devices

FDA 510(k) Submission Details - K904912

510(k) Number K904912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1990
Decision Date January 04, 1991
Days to Decision 65 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
65d faster than avg
Panel avg: 130d · This submission: 65d
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 K904912.
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
TRANSDUCER FILTER
K821268 · Cp Medical · Jun 1982