Cleared Traditional

K900382 - BLUBLOCKER SUNGLASSES

K900382 is an FDA 510(k) clearance for BLUBLOCKER 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 19-day FDA review.

K900382 · Blublocker Corp. · Ophthalmic device
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Feb 1990
Decision
19d
Days
Class 1
Risk

K900382 is an FDA 510(k) clearance for the BLUBLOCKER 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 February 13, 1990 after a review of 19 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 - K900382

510(k) Number K900382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1990
Decision Date February 13, 1990
Days to Decision 19 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
91d faster than avg
Panel avg: 110d · This submission: 19d
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 K900382.
MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP.
K900523 · J & B Assoc. · Feb 1990
MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE
K900525 · J & B Assoc. · Feb 1990
COLORVISION SUNGLASSES
K900381 · Blublocker Corp. · Feb 1990
BULLET SUNGLASSES
K900383 · Blublocker Corp. · Feb 1990
NOVELTY GRADUATION SUNGLASSES
K900046 · Gibson Greetings, Inc. · Jan 1990
PLASTIC SUNGLASSES
K896716 · Bright Horizon Ent. · Dec 1989
K900382 · BLUBLOCKER SUNGLASSES
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