Cleared Traditional

K863218 - CYTOSTATIC FILTRATION SET

K863218 is an FDA 510(k) clearance for CYTOSTATIC FILTRATION SET, manufactured by Meadox Surgimed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFK cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K863218 · Meadox Surgimed, Inc. · Gastroenterology & Urology device
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Feb 1987
Decision
176d
Days
Class 2
Risk

K863218 is an FDA 510(k) clearance for the CYTOSTATIC FILTRATION SET. Classified as Catheter, Femoral (product code LFK), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on February 12, 1987 after a review of 176 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 Meadox Surgimed, Inc. devices

FDA 510(k) Submission Details - K863218

510(k) Number K863218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1986
Decision Date February 12, 1987
Days to Decision 176 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
45d slower than avg
Panel avg: 131d · This submission: 176d
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 K863218.
CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY
K880775 · Medsurg Industries, Inc. · Jul 1988
VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER
K882466 · Vas-Cath, 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
MEDCOMP'S FEMORAL VEIN CATHETERS
K860810 · Medical Components, Inc. · Apr 1986
MAHURKAR FEMORAL CATHETER
K830674 · Quinton, Inc. · May 1983