Cleared Traditional

K962290 - DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER (FDA 510(k) Clearance)

Class I General Hospital device.

K962290 · Debusk Technology Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
19d
Days
Class 1
Risk

K962290 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER. Classified as Pad, Neonatal Eye (product code FOK), Class I - General Controls.

Submitted by Debusk Technology Corp. (Powell, US). The FDA issued a Cleared decision on July 3, 1996 after a review of 19 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Debusk Technology Corp. devices

Submission Details

510(k) Number K962290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1996
Decision Date July 03, 1996
Days to Decision 19 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 128d · This submission: 19d
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.