Cleared Traditional

K964316 - PLASTIC SUNGLASSES

K964316 is an FDA 510(k) clearance for PLASTIC SUNGLASSES, manufactured by Medical Reports Exchange, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K964316 · Medical Reports Exchange, Inc. · Ophthalmic device
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Dec 1996
Decision
49d
Days
Class 1
Risk

K964316 is an FDA 510(k) clearance for the PLASTIC SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Medical Reports Exchange, Inc. (Baltimore, US). The FDA issued a Cleared decision on December 17, 1996 after a review of 49 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 Medical Reports Exchange, Inc. devices

FDA 510(k) Submission Details - K964316

510(k) Number K964316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1996
Decision Date December 17, 1996
Days to Decision 49 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
61d faster than avg
Panel avg: 110d · This submission: 49d
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 K964316.
SUNGLASSES
K964564 · Micron Metal & Plastic Manufactory Co. · Jan 1997
SENNA
K964744 · Trans-America Enterprises Corp. · Jan 1997
GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES
K964505 · I C Optics, Ltd. · Jan 1997
SUNGLASSES OR MULTIPLE
K964429 · Trade Resources , Ltd. · Dec 1996
SPENSER SUNGLASSES AND SPORT SUNGLASSES
K964058 · Spencer Products Co. · Nov 1996
SUNGLASSES
K964082 · Neo Vu, Inc. · Nov 1996