Cleared Traditional

K821391 - OPHTHALMIC EYEWEAR

K821391 is an FDA 510(k) clearance for OPHTHALMIC EYEWEAR, manufactured by Nordic Eyewear, Inc.. The device is a Class 1 Ophthalmic device with product code HQZ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K821391 · Nordic Eyewear, Inc. · Ophthalmic device
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Jun 1982
Decision
49d
Days
Class 1
Risk

K821391 is an FDA 510(k) clearance for the OPHTHALMIC EYEWEAR. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Nordic Eyewear, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 29, 1982 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5842 - 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 - K821391

510(k) Number K821391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1982
Decision Date June 29, 1982
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.

HQZ Device Classification - Class 1, General Controls

Product Code HQZ Frame, Spectacle
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5842
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 - HQZ Frame, Spectacle

All 194
Devices cleared under the same product code (HQZ) and FDA review panel - the closest regulatory comparables to K821391.
OMYL -ARDE- SPECTACLE FRAME
K833401 · I.J. Langleb , Ltd. · Feb 1984
GLASS FRAMES & COMPONENT PARTS
K831388 · Anamar · Jun 1983
HANDPIECE SYSTEM I/A
K830413 · Uxtra Corp. · Apr 1983
ULTRA-WIDE SAFETY SPECTACLE FRAME
K813156 · Zee Medical Products Co., Inc. · Dec 1981
SPECTACLE FRAMES
K810876 · Fashionline Corp. · Sep 1981
EYEGLASS FRAMES
K810278 · Caesar Intl. Designs · Apr 1981
K821391 · OPHTHALMIC EYEWEAR
Download PDF Nordic Eyewear, Inc.