Cleared Traditional

K935231 - TALE SPIN SUNSHADES

K935231 is an FDA 510(k) clearance for TALE SPIN SUNSHADES, manufactured by Equity Marketing, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K935231 · Equity Marketing, Inc. · Ophthalmic device
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Jan 1994
Decision
85d
Days
Class 1
Risk

K935231 is an FDA 510(k) clearance for the TALE SPIN SUNSHADES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Equity Marketing, Inc. (New York, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5850 - 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: 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 Equity Marketing, Inc. devices

FDA 510(k) Submission Details - K935231

510(k) Number K935231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1993
Decision Date January 25, 1994
Days to Decision 85 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
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

HQY Device Classification - Class 1, General Controls

Product Code HQY Sunglasses (non-prescription Including Photosensitive)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5850
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.

Regulatory Peers - HQY Sunglasses (non-prescription Including Photosensitive)

All 124
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K935231.
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PHOTOCHROMIC LENS
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ASSENAT-BLESCHET SUNGLASSES
K885275 · Roseburg SA · Jan 1989