Cleared Traditional

K801922 - TUTTIFRUTTI (NON-PRES. SUNGLASSES)

K801922 is an FDA 510(k) clearance for TUTTIFRUTTI (NON-PRES. SUNGLASSES), manufactured by Safety Plastics of New York. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K801922 · Safety Plastics of New York · Ophthalmic device
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Nov 1980
Decision
92d
Days
Class 1
Risk

K801922 is an FDA 510(k) clearance for the TUTTIFRUTTI (NON-PRES. SUNGLASSES). Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Safety Plastics of New York (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 92 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K801922

510(k) Number K801922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1980
Decision Date November 12, 1980
Days to Decision 92 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
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 645
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K801922.
UVEX ALPHA, BETA, GAMMA & DELTA SUN
K820016 · Bacou USA, Inc. and Uvex Safety, Inc. · Mar 1982
FASHION SUNGLASSES
K803308 · Grand Imperial, Inc. · Apr 1981
POLARIS SPECTACLE FRAMES & LENSES
K802082 · Polaris Optics USA, Inc. · Feb 1981
LIBCO SUNGLASSES
K801196 · Libco Eyewear, Inc. · May 1980
RAY-BAN SUN GLASSES
K791499 · Bausch & Lomb, Inc. · Aug 1979
K801922 · TUTTIFRUTTI (NON-PRES. SUNGLASSES)
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