Cleared Traditional

K910501 - PERMANENT SILICONE CATHETERS

K910501 is an FDA 510(k) clearance for PERMANENT SILICONE CATHETERS, manufactured by Akcess Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K910501 · Akcess Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
83d
Days
Class 2
Risk

K910501 is an FDA 510(k) clearance for the PERMANENT SILICONE CATHETERS. 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 April 29, 1991 after a review of 83 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

FDA 510(k) Submission Details - K910501

510(k) Number K910501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1991
Decision Date April 29, 1991
Days to Decision 83 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
48d faster than avg
Panel avg: 131d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFJ Device Classification - Class 2, Special Controls

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 63
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K910501.
VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS
K914162 · Vas-Cath, Inc. · Jul 1993
HEMO-CATH SILICONE ACCESS CATHETER
K915423 · Medical Components, Inc. · Feb 1993
AKCESS-CATH KIT
K914826 · Akcess Medical Products, Inc. · Apr 1992
MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER
K905080 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1991
SINGLE LUMEN CATHETER KITS
K904139 · Akcess Medical Products, Inc. · Dec 1990
SINGLE LUMEN CATHETERS, MODIFICATION
K904140 · Akcess Medical Products, Inc. · Nov 1990