Cleared Traditional

CENTRAL VEIN CATHETERIZATION TRAY (K852642) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K852642 · Teleflexmedical, Inc. · Gastroenterology & Urology device
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Jan 1986
Decision
209d
Days
Class 1
Risk

K852642 is an FDA 510(k) clearance for the CENTRAL VEIN CATHETERIZATION TRAY. Classified as Attachment, Eyepiece, For Insertion Of Prescription Lens (product code FDZ), Class I - General Controls.

Submitted by Teleflexmedical, Inc. (Jeffrey, US). The FDA issued a Cleared decision on January 16, 1986 after a review of 209 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Teleflexmedical, Inc. devices

Submission Details

510(k) Number K852642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1985
Decision Date January 16, 1986
Days to Decision 209 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 130d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FDZ Attachment, Eyepiece, For Insertion Of Prescription Lens
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
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.