Cleared Traditional

K961523 - TINY TOON SUNGLASSES & CABBAGE PATCH KIDS SUNGLASSES

K961523 is an FDA 510(k) clearance for TINY TOON SUNGLASSES & CABBAGE PATCH KI..., manufactured by Dorda Toys. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K961523 · Dorda Toys · Ophthalmic device
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May 1996
Decision
21d
Days
Class 1
Risk

K961523 is an FDA 510(k) clearance for the TINY TOON SUNGLASSES & CABBAGE PATCH KIDS SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Dorda Toys (Monterey Park, US). The FDA issued a Cleared decision on May 13, 1996 after a review of 21 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 Dorda Toys devices

FDA 510(k) Submission Details - K961523

510(k) Number K961523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date May 13, 1996
Days to Decision 21 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 110d · This submission: 21d
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 123
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K961523.
STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSES
K961286 · Intl. Optical Mfg. Co., Ltd. · May 1996
CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY
K961746 · Eurotrends Eyewear, Inc. · May 1996
EVERGLORY SUNGLASSES
K960735 · Everglory Creations, Inc. · May 1996
SUN CLIP
K961603 · Intromark, Inc. · May 1996
AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE
K943145 · The Monticello Group, Inc. · Apr 1996
D & K SUNGLASSES
K960798 · D&K Stores, Inc. · Apr 1996