Cleared Traditional

K901161 - SOLAR SHADES(TM) SUNGLASSES

K901161 is an FDA 510(k) clearance for SOLAR SHADES(TM) SUNGLASSES, manufactured by Blublocker Corp.. 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.

K901161 · Blublocker Corp. · Ophthalmic device
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May 1990
Decision
49d
Days
Class 1
Risk

K901161 is an FDA 510(k) clearance for the SOLAR SHADES(TM) SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Blublocker Corp. (Northbrook, US). The FDA issued a Cleared decision on May 1, 1990 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.

FDA 510(k) Submission Details - K901161

510(k) Number K901161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1990
Decision Date May 01, 1990
Days to Decision 49 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
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 632
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K901161.
MODEL 8806 SD SUNGLASSES W/ACRYLIC LENSES
K900528 · J & B Assoc. · May 1990
MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES
K900529 · J & B Assoc. · May 1990
CHILDREN'S SUNGLASSES
K901468 · M. & S. Shillman, Inc. · May 1990
VECTRA(TM)
K901100 · Optical Coating Laboratory, Inc. · Apr 1990
NIKON MULTI-SPORT SUNGLASSES
K900090 · Oculus America · Mar 1990
DISCO SUNGLASSES (NON-PRESCRIPTION)
K900387 · Le-I Electronic Co. , Ltd. · Feb 1990
K901161 · SOLAR SHADES(TM) SUNGLASSES
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