Cleared Traditional

K940203 - TRIPLE LUMEN URODYNAMIC CATHETER WITH R...

K940203 is the FDA 510(k) clearance for TRIPLE LUMEN URODYNAMIC CATHETER WITH R... by Life-Tech Intl., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FEN) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K940203 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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Mar 1994
Decision
76d
Days
Class 2
Risk

K940203 is an FDA 510(k) clearance for the TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS. Classified as Device, Cystometric, Hydraulic (product code FEN), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on March 30, 1994 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 Life-Tech Intl., Inc. devices

Submission Details

510(k) Number K940203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1994
Decision Date March 30, 1994
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 FEN Device, Cystometric, Hydraulic
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 - FEN Device, Cystometric, Hydraulic

All 12
Devices cleared under the same product code (FEN) and FDA review panel - the closest regulatory comparables to K940203.
RUSCH URODYNAMIC RECTAL BALLOON CATHETER
K952573 · Rusch Intl. · Jun 1995
RUSCH INTERNATIONAL URODYNAMIC CATHETERS
K952029 · Rusch Intl. · Jun 1995
OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
K944391 · Surgitek · Feb 1995
STAND ALONE CYSTOMETROGRAM
K934141 · Medical Engineering Corp. · Nov 1993
KENDALL URODYNAMIC CATHETERS
K933399 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1993
SILICONE RECTAL BALLOON
K930135 · Cook Urological, Inc. · Oct 1993