Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HQZ — Predicate Candidate Screening

198 FDA 510(k) clearances under this product code; the 50 most recent screened below.

61 daysmedian FDA review time

162 days90th percentile

198clearances measured

K-number	Device	Applicant	Decided	Review days
K952597	VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY	Point of View Optical Outlet, Inc.	1995-09-12	98
K944313	SPECTACLE FRAME	Sun Hing Optical Manufactory , Ltd.	1995-03-28	211
K945392	SPECTACLE FRAME	Seo Han Corp., Ltd.	1994-12-15	42
K945176	SPECTACLE FRAME OR EYEGLASS FRAMES	Optipia Trading Co.	1994-12-15	52
K945770	OPTICAL FRAMES	Ramada Optics, Inc.	1994-12-15	43
K945350	FRAME, SPECTACLES	Taiwan Eva Industrial Co., Inc.	1994-12-13	90
K945342	MAG-1 SPECTACLE FRAME	Criss Optical Mfg. Co., Inc.	1994-11-28	27
K945123	ARISTAR EYEWEAR, ESPRIT EYEWEAR	Aristar Inc. U.S.A.	1994-11-22	34
K945340	SPECTACLE FRAMES OR EYEGLASS FRAMES	Mi Mun Corp.	1994-11-22	21
K945323	SPECTACLE FRAME	M.Y. Vision Corp.	1994-11-22	21
K945450	FRAME, SPECTACLE	Kookje Apis Industrial Co.	1994-11-22	19
K944641	NIL	Max-Vision (H.K.)Limited	1994-11-14	54
K944373	SPECTACLE FRAMES	Custom Optical Frames, Inc.	1994-09-28	21
K944160	SILHOUETTE, SUNLIMETED,ADIDAS	Silhouette Optical , Ltd.	1994-09-28	33
K943561	SPECTACLE FRAME	Australian Optical Co., Inc.	1994-09-14	54
K943641	SPECTACLE FRAME	Australian Optical Co., Inc.	1994-09-14	49
K943792	SPECTACLE FRAMES	Kt Optique, Inc.	1994-09-14	42
K943913	MAX FRAME DESIGN	Noble Optic	1994-09-07	27
K943423	SPECTACLE FRAMES	Galilee Optics	1994-09-06	53
K943753	FRAME SPECTACLE	Optic Tech Corp.	1994-09-02	31
K943567	FACONNABLE EYEWEAR	Blink Designs, Inc.	1994-08-10	19
K943326	SPECTACLE FRAMES	Buffard-La-Doye	1994-08-10	30
K942897	OPTHALMIC WIPE	Surgin Surgical Instrumentation, Inc.	1994-08-05	46
K942478	VISARD FRAMES	Iris Optical, Inc.	1994-08-05	72
K943507	WINK EYEWEAR	Wink Optical, Inc.	1994-08-05	16
K943265	N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMO	The First Optical Manufactory , Ltd.	1994-08-05	29
K943198	SPECTACLE FRAMES	Lunettes Folomi S.A.	1994-08-05	31
K943085	SPECTACLE FRAME	Winntics Optical Industry Co. , Ltd.	1994-08-04	37
K942845	PERSOL, MOSCLHINO, AND GERALD GENTA	Persol America, Inc.	1994-08-04	49
K943082	SPECTACLE FRAME	Daewon Optical Co.	1994-08-04	37
K943236	OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX	Optiline Imports and Trade, Inc.	1994-08-02	27
K943442	SPECTACLE FRAMES	Sunny Union Industrial Co., Ltd.	1994-08-02	15
K943083	SPECTACLE FRAME	Pimex Co., Ltd.	1994-08-02	35
K943086	SPECTACLE FRAME	Radiant Spectacles Manufacturers	1994-08-02	35
K943084	SPECTACLE FRAME	Samil Enterprise Co.	1994-07-25	27
K942750	SPECTACLE FRAMES	Aspex Eyewear, Inc.	1994-07-25	45
K942513	SEIKO EYEGLASS FRAME	Seiko Optical Products of America, Inc.	1994-07-15	50
K941414	EYECOTECH CORP	Eyecotech Corp.	1994-07-12	111
K942348	PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC.	Oliver Peoples, Inc.	1994-07-12	56
K942463	FRAME, SPECTACLE	Erica Optical Co.	1994-07-12	49
K940733	SPECTACLE FRAMES (V.I.P. INT'L)	Continental Optical Imports	1994-06-17	162
K941211	SPECTACLE FRAMES	H & M Optical (U.S.A.) , Ltd.	1994-06-17	99
K941463	SPECTACLE FRAMES, READING GLASSES	Well Arts Optical Factory , Ltd.	1994-06-17	81
K941767	FRAMES - VARIOUS BRAND NAMES	Lenscraft, Inc.	1994-06-03	53
K941602	SPECTACLE FRAMES	Slim Occhiali	1994-06-03	63
K941523	SPECTACLE FRAMES	Amore Mio, Inc.	1994-05-17	48
K940504	SPECTACLE FRAMES	Tecnol-Tecnica Nacional DE Oculos Ltda	1994-05-17	103
K941307	SPECTACLE FRAMES	Eyemart Express, Inc.	1994-05-17	61
K940977	SPECTACLE FRAMES	Super Optical, Inc.	1994-04-29	59
K940077	SPECTACLE FRAMES (WING SHING OPTICAL)	Continental Optical Imports	1994-04-12	96

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda