Cleared Traditional

K926118 - LIFE TRACE(R) BILIRUBIN MASK

K926118 is an FDA 510(k) clearance for LIFE TRACE BILIRUBIN MASK, manufactured by Graphic Controls Corp.. The device is a Class 1 General Hospital device with product code FOK cleared through the Traditional 510(k) pathway after a 102-day FDA review.

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

FDA 510(k) Submission Details - K926118

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 129d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

FOK Device Classification - Class 1, General Controls

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.