Cleared Traditional

K914363 - PERITONEAL DIALYSIS CYCLER SET

K914363 is an FDA 510(k) clearance for PERITONEAL DIALYSIS CYCLER SET, manufactured by National Medical Care, Medical Products Div., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K914363 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
167d
Days
Class 2
Risk

K914363 is an FDA 510(k) clearance for the PERITONEAL DIALYSIS CYCLER SET. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on March 16, 1992 after a review of 167 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 National Medical Care, Medical Products Div., Inc. devices

FDA 510(k) Submission Details - K914363

510(k) Number K914363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date March 16, 1992
Days to Decision 167 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
36d slower than avg
Panel avg: 131d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 298
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K914363.
HEMOCOR HP HEMOCONCENTRATOR SERIES
K923139 · Minntech Corp. · Feb 1994
HIGH PERMEABILITY DIALYER
K923312 · Minntech Corp. · Feb 1994
FRESENIUS POLYSULFONE DIALYZERS
K921134 · Fresenius USA, Inc. · Dec 1993
DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY
K913950 · Althin Medical AB an Affiliate of Baxter Intl · Nov 1991
INPERSOL CAPD BIOCAP ADMINISTRATION SET
K911094 · Abbott Laboratories · Apr 1991
RENAFLO HDF 1350 HEMODIAFILTER
K910236 · Minntech Corp. · Apr 1991