Cleared Abbreviated

K010366 - DISPOSABLE STORAGE CAP

K010366 is an FDA 510(k) clearance for DISPOSABLE STORAGE CAP, manufactured by Molded Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Abbreviated 510(k) pathway after a 294-day FDA review.

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

FDA 510(k) Submission Details - K010366

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.

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 96
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K010366.
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ULTRACONCENTRATOR SYSTEM
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K002761 · Fresenius Medical Care North America · Dec 2000
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
K980658 · Baxter Healthcare Corp · May 1998
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
K970708 · Terumo Medical Corp. · Dec 1997