Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: HQZ FDA class 1

Frame, Spectacle

Ophthalmic

View full classification →

A Spectacle Frame is the structural component of a pair of eyeglasses, designed to hold corrective or protective ophthalmic lenses in the correct position in front of the wearer's eyes, encompassing the front piece, temples, nose pads, and associated hardware. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HQZ and is regulated under 21 CFR 886.5842, within the Ophthalmic medical specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K952597

VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW

Sep 12, 1995

Substantially Equivalent

POINT OF VIEW OPTICAL OUTLET, INC.

K944313

SPECTACLE FRAME

Mar 28, 1995

Substantially Equivalent

SUN HING OPTICAL MANUFACTORY LTD.

K945176

SPECTACLE FRAME OR EYEGLASS FRAMES

Dec 15, 1994

Substantially Equivalent

OPTIPIA TRADING CO.

K945770

OPTICAL FRAMES

Dec 15, 1994

Substantially Equivalent

RAMADA OPTICS, INC.

K945392

SPECTACLE FRAME

Dec 15, 1994

Substantially Equivalent

SEO HAN CORP., LTD.

K945350

FRAME, SPECTACLES

Dec 13, 1994

Substantially Equivalent

TAIWAN EVA INDUSTRIAL CO., INC.

K945342

MAG-1 SPECTACLE FRAME

Nov 28, 1994

Substantially Equivalent

CRISS OPTICAL MFG. CO., INC.

K945340

SPECTACLE FRAMES OR EYEGLASS FRAMES

Nov 22, 1994

Substantially Equivalent

MI MUN CORP.

K945323

SPECTACLE FRAME

Nov 22, 1994

Substantially Equivalent

M.Y. VISION CORP.

K945450

FRAME, SPECTACLE

Nov 22, 1994

Substantially Equivalent

KOOKJE APIS INDUSTRIAL CO.

K945123

ARISTAR EYEWEAR, ESPRIT EYEWEAR

Nov 22, 1994

Substantially Equivalent

ARISTAR INC. U.S.A.

K944641

NIL

Nov 14, 1994

Substantially Equivalent

MAX-VISION (H.K.)LIMITED

K944160

SILHOUETTE, SUNLIMETED,ADIDAS

Sep 28, 1994

Substantially Equivalent

SILHOUETTE OPTICAL LTD.

K944373

SPECTACLE FRAMES

Sep 28, 1994

Substantially Equivalent

CUSTOM OPTICAL FRAMES, INC.

K943561

SPECTACLE FRAME

Sep 14, 1994

Substantially Equivalent

AUSTRALIAN OPTICAL CO., INC.

K943641

SPECTACLE FRAME

Sep 14, 1994

Substantially Equivalent

AUSTRALIAN OPTICAL CO., INC.

K943792

SPECTACLE FRAMES

Sep 14, 1994

Substantially Equivalent

KT OPTIQUE, INC.

K943913

MAX FRAME DESIGN

Sep 07, 1994

Substantially Equivalent

NOBLE OPTIC

K943423

SPECTACLE FRAMES

Sep 06, 1994

Substantially Equivalent

GALILEE OPTICS

K943753

FRAME SPECTACLE

Sep 02, 1994

Substantially Equivalent

OPTIC TECH CORP.

K943326

SPECTACLE FRAMES

Aug 10, 1994

Substantially Equivalent

BUFFARD-LA-DOYE

K943567

FACONNABLE EYEWEAR

Aug 10, 1994

Substantially Equivalent

BLINK DESIGNS, INC.

K943265

N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMO

Aug 05, 1994

Substantially Equivalent

THE FIRST OPTICAL MANUFACTORY LTD.

K943507

WINK EYEWEAR

Aug 05, 1994

Substantially Equivalent

WINK OPTICAL, INC.

K942478

VISARD FRAMES

Aug 05, 1994

Substantially Equivalent

IRIS OPTICAL, INC.

K942897

OPTHALMIC WIPE

Aug 05, 1994

Substantially Equivalent

SURGIN SURGICAL INSTRUMENTATION, INC.

K943198

SPECTACLE FRAMES

Aug 05, 1994

Substantially Equivalent

LUNETTES FOLOMI S.A.

K943082

SPECTACLE FRAME

Aug 04, 1994

Substantially Equivalent

DAEWON OPTICAL CO.

K943085

SPECTACLE FRAME

Aug 04, 1994

Substantially Equivalent

WINNTICS OPTICAL INDUSTRY CO. LTD.

K942845

PERSOL, MOSCLHINO, AND GERALD GENTA

Aug 04, 1994

Substantially Equivalent

PERSOL AMERICA, INC.

K943442

SPECTACLE FRAMES

Aug 02, 1994

Substantially Equivalent

SUNNY UNION INDUSTRIAL CO., LTD.

K943086

SPECTACLE FRAME

Aug 02, 1994

Substantially Equivalent

RADIANT SPECTACLES MANUFACTURERS

K943236

OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX

Aug 02, 1994

Substantially Equivalent

OPTILINE IMPORTS AND TRADE, INC.

K943083

SPECTACLE FRAME

Aug 02, 1994

Substantially Equivalent

PIMEX CO., LTD.

K942750

SPECTACLE FRAMES

Jul 25, 1994

Substantially Equivalent

ASPEX EYEWEAR, INC.

K943084

SPECTACLE FRAME

Jul 25, 1994

Substantially Equivalent

SAMIL ENTERPRISE CO.

K942513

SEIKO EYEGLASS FRAME

Jul 15, 1994

Substantially Equivalent

SEIKO OPTICAL PRODUCTS OF AMERICA, INC.

K942348

PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC.

Jul 12, 1994

Substantially Equivalent

OLIVER PEOPLES, INC.

K942463

FRAME, SPECTACLE

Jul 12, 1994

Substantially Equivalent

ERICA OPTICAL CO.

K941414

EYECOTECH CORP

Jul 12, 1994

Substantially Equivalent

EYECOTECH CORP.

K941463

SPECTACLE FRAMES, READING GLASSES

Jun 17, 1994

Substantially Equivalent

WELL ARTS OPTICAL FACTORY LTD.

K940733

SPECTACLE FRAMES (V.I.P. INT'L)

Jun 17, 1994

Substantially Equivalent

CONTINENTAL OPTICAL IMPORTS

K941211

SPECTACLE FRAMES

Jun 17, 1994

Substantially Equivalent

H & M OPTICAL (U.S.A.) LTD.

K941602

SPECTACLE FRAMES

Jun 03, 1994

Substantially Equivalent

SLIM OCCHIALI

K941767

FRAMES - VARIOUS BRAND NAMES

Jun 03, 1994

Substantially Equivalent

LENSCRAFT, INC.

K941523

SPECTACLE FRAMES

May 17, 1994

Substantially Equivalent

AMORE MIO, INC.

K940504

SPECTACLE FRAMES

May 17, 1994

Substantially Equivalent

TECNOL-TECNICA NACIONAL DE OCULOS LTDA

K941307

SPECTACLE FRAMES

May 17, 1994

Substantially Equivalent

EYEMART EXPRESS, INC.

K940977

SPECTACLE FRAMES

Apr 29, 1994

Substantially Equivalent

SUPER OPTICAL, INC.

K940077

SPECTACLE FRAMES (WING SHING OPTICAL)

Apr 12, 1994

Substantially Equivalent

CONTINENTAL OPTICAL IMPORTS

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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