Cleared Traditional

K914407 - PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)

K914407 is an FDA 510(k) clearance for PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIP..., manufactured by Promedex, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K914407 · Promedex, Inc. · Ophthalmic device
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Dec 1991
Decision
90d
Days
Class 1
Risk

K914407 is an FDA 510(k) clearance for the PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION). Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Promedex, Inc. (Fort Woth, US). The FDA issued a Cleared decision on December 31, 1991 after a review of 90 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 - K914407

510(k) Number K914407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1991
Decision Date December 31, 1991
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
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 K914407.
SUNGLASSES (NON-PRESCRIPTION)
K920165 · Blair Corporation · Feb 1992
SUN SIGHT SUNGLASSES/SUN SIGHT READING GLASSES
K914766 · Sun Sight Glasses Co., Ltd. · Jan 1992
MOSSIMO OPTIC EYEWEAR
K912509 · Mossimo, Inc. · Jan 1992
PYRAMID SUNGLASSES/READING GLASSES
K914425 · Pyramid · Dec 1991
DR. DEAN EDELL SOLARBLOC SUNGLASSES
K913640 · Cable Car Sunglasses · Oct 1991
DUCAL SIDE SHIELD SUNGLASS
K913745 · Ducal Trading Corp. · Oct 1991
K914407 · PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)
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