Cleared Traditional

K810876 - SPECTACLE FRAMES

K810876 is an FDA 510(k) clearance for SPECTACLE FRAMES, manufactured by Fashionline Corp.. The device is a Class 1 Ophthalmic device with product code HQZ cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K810876 · Fashionline Corp. · Ophthalmic device
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Sep 1981
Decision
174d
Days
Class 1
Risk

K810876 is an FDA 510(k) clearance for the SPECTACLE FRAMES. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Fashionline Corp. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981 after a review of 174 days - an extended review 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: 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 - K810876

510(k) Number K810876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1981
Decision Date September 21, 1981
Days to Decision 174 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
64d slower than avg
Panel avg: 110d · This submission: 174d
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 K810876.
HANDPIECE SYSTEM I/A
K830413 · Uxtra Corp. · Apr 1983
OPHTHALMIC EYEWEAR
K821391 · Nordic Eyewear, Inc. · Jun 1982
ULTRA-WIDE SAFETY SPECTACLE FRAME
K813156 · Zee Medical Products Co., Inc. · Dec 1981
EYEGLASS FRAMES
K810278 · Caesar Intl. Designs · Apr 1981
SPECTACLE FRAME, OP-TITE
K772368 · Dentsply Intl. · Jan 1978
MEMLITE (PLASTIC EYEGLASS FRAMES)
K770221 · American Optical Corp. · Feb 1977
K810876 · SPECTACLE FRAMES
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