Cleared Traditional

K915443 - URODYNAMIC CATHETER

K915443 is the FDA 510(k) clearance for URODYNAMIC CATHETER by Cook Urological, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAP) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K915443 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
76d
Days
Class 2
Risk

K915443 is an FDA 510(k) clearance for the URODYNAMIC CATHETER. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on February 19, 1992 after a review of 76 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 Cook Urological, Inc. devices

Submission Details

510(k) Number K915443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1991
Decision Date February 19, 1992
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 130d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K915443.
UROLAB SPECTRUM
K931179 · Life-Tech Intl., Inc. · Nov 1993
URETHRALPRESSURE PROFILE CATHETER
K915484 · Life-Tech Intl., Inc. · Feb 1992
DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST
K913736 · Biosearch Medical Products, Inc. · Feb 1992
URODYNAMIC RECTAL BALLOON
K912451 · Cook Urological, Inc. · Dec 1991
UROLAB JANUS
K904386 · Life-Tech Intl., Inc. · Nov 1990
BIOSEARCH ANAL BIOFEEDBACK DEVICE
K902843 · Biosearch Medical Products, Inc. · Sep 1990