Cleared Traditional

K915215 - CONTINUOUS ARTERIOVENOUS HEMOFILTRATION...

K915215 is the FDA 510(k) clearance for CONTINUOUS ARTERIOVENOUS HEMOFILTRATION... by Akcess Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LFK) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K915215 · Akcess Medical Products, Inc. · Gastroenterology & Urology device
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Mar 1992
Decision
130d
Days
Class 2
Risk

K915215 is an FDA 510(k) clearance for the CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS. Classified as Catheter, Femoral (product code LFK), Class II - Special Controls.

Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on March 27, 1992 after a review of 130 days - within the typical 510(k) review window.

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 K915215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 18, 1991
Decision Date March 27, 1992
Days to Decision 130 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
At panel average
Panel avg: 130d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFK Catheter, Femoral
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 - LFK Catheter, Femoral

All 9
Devices cleared under the same product code (LFK) and FDA review panel - the closest regulatory comparables to K915215.
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET
K914936 · Akcess Medical Products, Inc. · Apr 1992
FC-100 FEMORAL CATHETER
K891763 · Akcess Medical Products, Inc. · Apr 1989
FC-101 FEMORAL CATHETER GUIDE WIRE
K891764 · Akcess Medical Products, Inc. · Apr 1989
CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY
K880775 · Medsurg Industries, Inc. · Jul 1988
NEW SECOND FRENCH SIZE MAHURKAR CATHETER
K865096 · Quinton, Inc. · Feb 1987
MEDCOMP C.A.V.H. CATHETER
K862771 · Medical Components, Inc. · Aug 1986