Cleared Traditional

K003712 - MODIFICATION TO MALE TO MALE LUER ADAPTER

K003712 is an FDA 510(k) clearance for MODIFICATION TO MALE TO MALE LUER ADAPTER, manufactured by Molded Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K003712 · Molded Products, Inc. · Gastroenterology & Urology device
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May 2001
Decision
166d
Days
Class 2
Risk

K003712 is an FDA 510(k) clearance for the MODIFICATION TO MALE TO MALE LUER ADAPTER. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Molded Products, Inc. (Harlan, US). The FDA issued a Cleared decision on May 16, 2001 after a review of 166 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 Molded Products, Inc. devices

FDA 510(k) Submission Details - K003712

510(k) Number K003712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2000
Decision Date May 16, 2001
Days to Decision 166 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
36d slower than avg
Panel avg: 130d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 123
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