Cleared Traditional

K962169 - MAGNETO EYEWEAR

K962169 is an FDA 510(k) clearance for MAGNETO EYEWEAR, manufactured by Nike, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K962169 · Nike, Inc. · Ophthalmic device
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Jun 1996
Decision
19d
Days
Class 1
Risk

K962169 is an FDA 510(k) clearance for the MAGNETO EYEWEAR. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Nike, Inc. (Beaverton, US). The FDA issued a Cleared decision on June 24, 1996 after a review of 19 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 Nike, Inc. devices

FDA 510(k) Submission Details - K962169

510(k) Number K962169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1996
Decision Date June 24, 1996
Days to Decision 19 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
91d faster than avg
Panel avg: 110d · This submission: 19d
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 K962169.
NON-GENERIC
K962310 · Classic Elegance Intl., Inc. · Jul 1996
NIKE V8 AND NIKE V12
K962412 · Nike, Inc. · Jul 1996
SUNGLASSES
K962436 · Chungsin Kau Optical Mfy. Co. , Ltd. · Jul 1996
IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5
K962107 · Leonachi, Inc. · Jun 1996
NON-PRESCRIPTION SUNGLASSES
K961990 · Rokko Stars Co., Ltd. · Jun 1996
MISTRAL SUNGLASSES
K960668 · Mistral Optical · May 1996