Cleared Traditional

K950016 - CART

K950016 is an FDA 510(k) clearance for CART, manufactured by Laborie Medical Tech Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FEN cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K950016 · Laborie Medical Tech Corp. · Gastroenterology & Urology device
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Mar 1995
Decision
86d
Days
Class 2
Risk

K950016 is an FDA 510(k) clearance for the CART, MODE NUMBER UDS-CART. Classified as Device, Cystometric, Hydraulic (product code FEN), Class II - Special Controls.

Submitted by Laborie Medical Tech Corp. (Mississauga, CA). The FDA issued a Cleared decision on March 30, 1995 after a review of 86 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 Laborie Medical Tech Corp. devices

FDA 510(k) Submission Details - K950016

510(k) Number K950016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1995
Decision Date March 30, 1995
Days to Decision 86 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
44d faster than avg
Panel avg: 130d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEN Device Classification - Class 2, Special Controls

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 13
Devices cleared under the same product code (FEN) and FDA review panel - the closest regulatory comparables to K950016.
UROVISION JANUS
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TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS
K940203 · Life-Tech Intl., Inc. · Mar 1994
STAND ALONE CYSTOMETROGRAM
K934141 · Medical Engineering Corp. · Nov 1993