Cleared Traditional

CABLE CAR SUNGLASSES (K914975) - FDA 510(k) Clearance

Class I Ophthalmic device.

K914975 · Cable Car Sunglasses · Ophthalmic device
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Mar 1992
Decision
146d
Days
Class 1
Risk

K914975 is an FDA 510(k) clearance for the CABLE CAR SUNGLASSES. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Cable Car Sunglasses (Hollister, US). The FDA issued a Cleared decision on March 31, 1992 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5842 - 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 Cable Car Sunglasses devices

Submission Details

510(k) Number K914975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1991
Decision Date March 31, 1992
Days to Decision 146 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
36d slower than avg
Panel avg: 110d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQZ Frame, Spectacle
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5842
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.