Cleared Special

K994218 - EASY CARE AND TUBING SETS

K994218 is an FDA 510(k) clearance for EASY CARE AND TUBING SETS, manufactured by Medionics International, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Special 510(k) pathway after a 57-day FDA review.

K994218 · Medionics International, Inc. · Gastroenterology & Urology device
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Feb 2000
Decision
57d
Days
Class 2
Risk

K994218 is an FDA 510(k) clearance for the EASY CARE AND TUBING SETS. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Medionics International, Inc. (Markham, Ontario, CA). The FDA issued a Cleared decision on February 10, 2000 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K994218

510(k) Number K994218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1999
Decision Date February 10, 2000
Days to Decision 57 days
Submission Type Special
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
74d faster than avg
Panel avg: 131d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

FKX Device Classification - Class 2, Special Controls

Product Code FKX System, Peritoneal, Automatic Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FKX System, Peritoneal, Automatic Delivery

All 82
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K994218.
FRESENIUS LIBERTY CYCLER
K043363 · Fresenius Medical Care North America · Mar 2005
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
K012988 · Baxter Healthcare Corp · Dec 2001
FRSENIUS PD IQCARD CYCLER
K002892 · Fresenius Medical Care North America · Apr 2001
BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST
K935659 · Baxter Healthcare Corp · Jul 1994
BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
K923065 · Baxter Healthcare Corp · Mar 1994
R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260
K933687 · R & D Batteries, Inc. · Feb 1994
K994218 · EASY CARE AND TUBING SETS
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