Cleared Traditional

K950602 - PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS

K950602 is an FDA 510(k) clearance for PORT CAPS (PROTECTIVE CLOSURES FOE REPR..., manufactured by Reprocessing Products Corp. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K950602 · Reprocessing Products Corp · Gastroenterology & Urology device
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Nov 1995
Decision
294d
Days
Class 2
Risk

K950602 is an FDA 510(k) clearance for the PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Reprocessing Products Corp (Tucson, US). The FDA issued a Cleared decision on November 30, 1995 after a review of 294 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 Reprocessing Products Corp devices

FDA 510(k) Submission Details - K950602

510(k) Number K950602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1995
Decision Date November 30, 1995
Days to Decision 294 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 131d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJI Device Classification - Class 2, Special Controls

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 118
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K950602.
BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL
K961026 · Dayspring Medical, Inc. · Jun 1996
COBE CENTRYSYSTEM CS 200 DIALYZER
K944436 · Cobe Renal Care, Inc. · Jan 1996
FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
K952343 · National Medical Care, Medical Products Div., Inc. · Dec 1995
MCA(TM) 180 HEMODIALYZER
K945622 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
FILTRYZER(TM)
K935471 · Toray Industries (America), Inc. · May 1995
MCA(TM) 130 HEMODIALYZER
K945623 · Althin Medical AB an Affiliate of Baxter Intl · May 1995