Cleared Traditional

GOGGLE SAFEGUARD (K931254) - FDA 510(k) Clearance

Class I Ophthalmic device.

K931254 · Sellstrom Mfg. Co. · Ophthalmic device
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Nov 1993
Decision
245d
Days
Class 1
Risk

K931254 is an FDA 510(k) clearance for the GOGGLE SAFEGUARD. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Sellstrom Mfg. Co. (Palatine, US). The FDA issued a Cleared decision on November 12, 1993 after a review of 245 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4750 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sellstrom Mfg. Co. devices

Submission Details

510(k) Number K931254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1993
Decision Date November 12, 1993
Days to Decision 245 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 110d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
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.