Cleared Abbreviated

DISPOSABLE STORAGE CAP (K010366) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K010366 · Molded Products, Inc. · Gastroenterology & Urology device
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Nov 2001
Decision
294d
Days
Class 2
Risk

K010366 is an FDA 510(k) clearance for the DISPOSABLE STORAGE CAP. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Molded Products, Inc. (Harlan, US). The FDA issued a Cleared decision on November 28, 2001 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Molded Products, Inc. devices

Submission Details

510(k) Number K010366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2001
Decision Date November 28, 2001
Days to Decision 294 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 130d · This submission: 294d
Pathway characteristics
Standards-based clearance path.

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 130
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K010366.
Hemoflow F3 and F4 Dialyzers
K190459 · Fresenius Medical Care Renal Therapies Group, LLC · Aug 2019
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
K980658 · Baxter Healthcare Corp · May 1998
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
K963933 · Baxter Healthcare Corp · Nov 1997
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950454 · Baxter Healthcare Corp · Apr 1995
BAXTER CA DIALYZER
K926567 · Baxter Healthcare Corp · Jan 1995
MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ
K905228 · Baxter Healthcare Corp · Dec 1990