Cleared Traditional

K914936 - CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET

K914936 is an FDA 510(k) clearance for CONTINUOUS ARTERIOVENOUS HEMOFILTRATION..., manufactured by Akcess Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFK cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K914936 · Akcess Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
171d
Days
Class 2
Risk

K914936 is an FDA 510(k) clearance for the CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET. 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 April 23, 1992 after a review of 171 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

FDA 510(k) Submission Details - K914936

510(k) Number K914936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 04, 1991
Decision Date April 23, 1992
Days to Decision 171 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
40d slower than avg
Panel avg: 131d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFK Device Classification - Class 2, Special Controls

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 13
Devices cleared under the same product code (LFK) and FDA review panel - the closest regulatory comparables to K914936.
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)
K971897 · Medron, Inc. · Oct 1997
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS
K915215 · Akcess Medical Products, Inc. · Mar 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
MODIFICATION HEMOFILTRATION CATHETER HF-100
K890717 · Vas-Cath, Inc. · Apr 1989
CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY
K880775 · Medsurg Industries, Inc. · Jul 1988