Cleared Traditional

K926118 - LIFE TRACE(R) BILIRUBIN MASK (FDA 510(k) Clearance)

Class I General Hospital device.

K926118 · Graphic Controls Corp. · General Hospital
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Mar 1993
Decision
102d
Days
Class 1
Risk

K926118 is an FDA 510(k) clearance for the LIFE TRACE(R) BILIRUBIN MASK. Classified as Pad, Neonatal Eye (product code FOK), Class I - General Controls.

Submitted by Graphic Controls Corp. (Buffalo, US). The FDA issued a Cleared decision on March 15, 1993 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5270 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Graphic Controls Corp. devices

Submission Details

510(k) Number K926118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1992
Decision Date March 15, 1993
Days to Decision 102 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 128d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FOK Pad, Neonatal Eye
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5270
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.