Cleared Traditional

K863044 - CAPILLARY FLOW HOLLOW FIBER DIALYZERS

K863044 is the FDA 510(k) clearance for CAPILLARY FLOW HOLLOW FIBER DIALYZERS by National Medical Care, Medical Products Div., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJI) cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K863044 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Mar 1987
Decision
228d
Days
Class 2
Risk

K863044 is an FDA 510(k) clearance for the CAPILLARY FLOW HOLLOW FIBER DIALYZERS. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on March 27, 1987 after a review of 228 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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

Submission Details

510(k) Number K863044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1986
Decision Date March 27, 1987
Days to Decision 228 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
98d slower than avg
Panel avg: 130d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJI Dialyzer, Capillary, Hollow Fiber
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FJI Dialyzer, Capillary, Hollow Fiber

All 84
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K863044.
CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
K871471 · Travenol Laboratories, S.A. · Jun 1987
HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H
K871236 · National Medical Care, Medical Products Div., Inc. · May 1987
CAPILLARY FLOW DIALYZERS
K870169 · Travenol Laboratories, S.A. · Apr 1987
COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS
K864831 · Cobe Laboratories, Inc. · Mar 1987
DISSCAP 80E, 110E, 140E, 160E
K863592 · Hospal Medical Corp. · Sep 1986
TORAY FILTRYZER DIALYZER, B1-2.0.
K862693 · National Medical Care, Medical Products Div., Inc. · Jul 1986