Cleared Traditional

SINGLE LUMEN CATHETER KITS (K904139) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904139 · Akcess Medical Products, Inc. · Gastroenterology & Urology device
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Dec 1990
Decision
89d
Days
Class 2
Risk

K904139 is an FDA 510(k) clearance for the SINGLE LUMEN CATHETER KITS. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on December 4, 1990 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Akcess Medical Products, Inc. devices

Submission Details

510(k) Number K904139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 06, 1990
Decision Date December 04, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 130d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFJ Catheter, Subclavian
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - LFJ Catheter, Subclavian

All 10
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K904139.
ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
K913468 · Cook, Inc. · Mar 1994
SUBCLAVIAN HEMODIALYSIS CATHETER
K884322 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1989
MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA
K881290 · Shiley, Inc. · Apr 1988
MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
K863697 · Shiley, Inc. · Oct 1986
SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
K861174 · Shiley, Inc. · Apr 1986
SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL
K852070 · Shiley, Inc. · Jun 1985