Cleared Abbreviated

DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES (K010712) - FDA 510(k) Clearance

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

K010712 · Molded Products, Inc. · Gastroenterology & Urology device
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Sep 2001
Decision
202d
Days
Class 2
Risk

K010712 is an FDA 510(k) clearance for the DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES. Classified as Tubing, Dialysate (product code FID), Class II - Special Controls.

Submitted by Molded Products, Inc. (Harlan, US). The FDA issued a Cleared decision on September 27, 2001 after a review of 202 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 K010712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2001
Decision Date September 27, 2001
Days to Decision 202 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
72d slower than avg
Panel avg: 130d · This submission: 202d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FID Tubing, Dialysate
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.