Cleared Traditional

L-CATH CONNECTOR ASSEMBLY (K940198) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K940198 · Luther Medical Products, Inc. · General & Plastic Surgery device
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Dec 1994
Decision
336d
Days
Class 1
Risk

K940198 is an FDA 510(k) clearance for the L-CATH CONNECTOR ASSEMBLY. Classified as Connector, Catheter (product code GCD), Class I - General Controls.

Submitted by Luther Medical Products, Inc. (Tustin, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Luther Medical Products, Inc. devices

Submission Details

510(k) Number K940198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1994
Decision Date December 15, 1994
Days to Decision 336 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 115d · This submission: 336d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GCD Connector, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.