Cleared Traditional

K943145 - AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE

K943145 is an FDA 510(k) clearance for AMERICAN, manufactured by The Monticello Group, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 669-day FDA review.

K943145 · The Monticello Group, Inc. · Ophthalmic device
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Apr 1996
Decision
669d
Days
Class 1
Risk

K943145 is an FDA 510(k) clearance for the AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by The Monticello Group, Inc. (Strafford, US). The FDA issued a Cleared decision on April 29, 1996 after a review of 669 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all The Monticello Group, Inc. devices

FDA 510(k) Submission Details - K943145

510(k) Number K943145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1994
Decision Date April 29, 1996
Days to Decision 669 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
559d slower than avg
Panel avg: 110d · This submission: 669d
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 K943145.
EVERGLORY SUNGLASSES
K960735 · Everglory Creations, Inc. · May 1996
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K961523 · Dorda Toys · May 1996
SUN CLIP
K961603 · Intromark, Inc. · May 1996
D & K SUNGLASSES
K960798 · D&K Stores, Inc. · Apr 1996
SUNGLASSES
K961034 · Kylie Enterprise Co. , Ltd. · Apr 1996
VISARD SUNGLASSES
K961117 · Visard Srl · Apr 1996