Cleared Traditional

K915484 - URETHRALPRESSURE PROFILE CATHETER

K915484 is an FDA 510(k) clearance for URETHRALPRESSURE PROFILE CATHETER, manufactured by Life-Tech Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K915484 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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Feb 1992
Decision
80d
Days
Class 2
Risk

K915484 is an FDA 510(k) clearance for the URETHRALPRESSURE PROFILE CATHETER. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on February 24, 1992 after a review of 80 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 Life-Tech Intl., Inc. devices

FDA 510(k) Submission Details - K915484

510(k) Number K915484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1991
Decision Date February 24, 1992
Days to Decision 80 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
51d faster than avg
Panel avg: 131d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

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 39
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K915484.
UROLAB SPECTRUM
K931179 · Life-Tech Intl., Inc. · Nov 1993
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO
K924383 · Synectics-Dantec · Jun 1993
ENDOTEK ULTRA SYSTEM
K920451 · Surgitek · Sep 1992
URODYNAMIC CATHETER
K915443 · Cook Urological, Inc. · Feb 1992
DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST
K913736 · Biosearch Medical Products, Inc. · Feb 1992
DANTEC UD 5500 MK2
K913169 · Dantec Medical, Inc. · Jan 1992