Cleared Traditional

K850790 - DIAFLEX OCCLUSION BALLOON CATHETER

K850790 is the FDA 510(k) clearance for DIAFLEX OCCLUSION BALLOON CATHETER by American Edwards Laboratories. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K850790 · American Edwards Laboratories · Gastroenterology & Urology device
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Mar 1985
Decision
27d
Days
Class 2
Risk

K850790 is an FDA 510(k) clearance for the DIAFLEX OCCLUSION BALLOON CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on March 25, 1985 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 American Edwards Laboratories devices

Submission Details

510(k) Number K850790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1985
Decision Date March 25, 1985
Days to Decision 27 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 115
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K850790.
TROCAR/CANNULA/SHEATH SET
K853337 · American Edwards Laboratories · Aug 1985
VAN-TEC GUIDE WIRE W/HYDROMER COATING
K851160 · Van-Tec, Inc. · Jul 1985
UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER
K851857 · Sheridan Catheter Corp. · Jul 1985
NORTA SILICONIZED LATEX BALLOON CATH.
K842420 · Beiersdorf, Inc. · Nov 1984
PERCUFIX CATHETER CUFF
K842890 · Medi-Tech, Inc. · Sep 1984
VAN-TEC OCCLUSION BALLOON CATHETER
K841941 · Van-Tec, Inc. · Aug 1984