Cleared Traditional

K970944 - BARAKKA, INFERNO, STERLING, AND/OR ONE

K970944 is an FDA 510(k) clearance for BARAKKA, manufactured by Sentinal Importing Corp.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K970944 · Sentinal Importing Corp. · Ophthalmic device
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May 1997
Decision
54d
Days
Class 1
Risk

K970944 is an FDA 510(k) clearance for the BARAKKA, INFERNO, STERLING, AND/OR ONE. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Sentinal Importing Corp. (North Vancouver, B.C., CA). The FDA issued a Cleared decision on May 6, 1997 after a review of 54 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 Sentinal Importing Corp. devices

FDA 510(k) Submission Details - K970944

510(k) Number K970944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1997
Decision Date May 06, 1997
Days to Decision 54 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
56d faster than avg
Panel avg: 110d · This submission: 54d
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 59
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K970944.
HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION)
K970476 · Hwa Mao Optical Co., Ltd. · May 1997
SOLAR SPECS
K970759 · Morris Rosenbloom & Co., Inc. · May 1997
CUSTOM OPTICAL SUNGLASS FRAMES
K970895 · Custom Optical Frames, Inc. · May 1997
CLASSIC MATCH
K971104 · Delagar Division Belcam, Inc. · May 1997
GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN
K971249 · Andrew G. Halpern · May 1997
ARROW COMPANY
K971326 · Excel Eyewear Corp. · May 1997