Cleared Traditional

K914826 - AKCESS-CATH KIT

K914826 is the FDA 510(k) clearance for AKCESS-CATH KIT by Akcess Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LFJ) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K914826 · Akcess Medical Products, Inc. · Gastroenterology & Urology device
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Apr 1992
Decision
168d
Days
Class 2
Risk

K914826 is an FDA 510(k) clearance for the AKCESS-CATH KIT. 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 10, 1992 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Akcess Medical Products, Inc. devices

Submission Details

510(k) Number K914826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 25, 1991
Decision Date April 10, 1992
Days to Decision 168 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
38d slower than avg
Panel avg: 130d · This submission: 168d
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 47
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K914826.
SPLITTABLE SHEATH INTRODUCER SET
K920634 · Akcess Medical Products, Inc. · Jan 1994
COAXIAL ACUTE CATHETER
K931120 · Akcess Medical Products, Inc. · Jan 1994
HEMO-CATH SILICONE ACCESS CATHETER
K915423 · Medical Components, Inc. · Feb 1993
PERMANENT SILICONE CATHETERS
K910501 · Akcess Medical Products, Inc. · Apr 1991
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