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

HQG — Predicate Candidate Screening

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

44 daysmedian FDA review time

140 days90th percentile

56clearances measured

K-number	Device	Applicant	Decided	Review days
K935919	SUNGLASSES	Ja-Ru, Inc.	1994-02-16	70
K920795	0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX	Optical Radiation Corp.	1992-07-13	143
K900091	MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR	Onufryk Low Vision Ent.	1990-04-04	89
K884360	SEIKO P-6 PROGRESSIVE SPECTACLE LENSES	Seiko Corp.	1988-11-15	29
K882814	NEOLENS PRESCRIPTION SPECTACLE LENS	Neolens, Inc.	1988-07-29	21
K882308	CR-39 PLASTIC LENSES FOR EYEGLASSES	Automated Lens System	1988-07-22	49
K881225	OPHTHALMIC SPECTACLE LENS BLANKS	Beta Optical Co, Inc.	1988-04-19	28
K875063	SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.	Epson EL Paso, Inc.	1988-02-22	75
K874681	SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES	Klockner Contract Packaging, Inc.	1988-02-05	84
K873245	AR DIACOAT SINGLE VISION LENSES	Seiko Optical Products of America, Inc.	1987-10-05	49
K872506	MELANITE I	Aura Lens Products	1987-07-27	33
K871961	MULTIPLE SPECTACLE LENS	Korea Asahi Optical Co., Ltd.	1987-06-03	14
K865103	KROM-X LENS SYSTEM	Neo Optics, Inc.	1987-01-20	21
K863367	FORMALENS 2000	Vision-Sciences, Inc.	1986-09-26	23
K862578	TECHNA VISION CASTING RESIN	Techna Vision	1986-07-23	16
K861021	GOTTEX SUNGLASSES	Private Eyes Sunglass Corp.	1986-06-17	91
K861684	SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)	Seiko Optical Products of America, Inc.	1986-06-09	38
K861162	LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)	Efop	1986-06-09	73
K861960	ZIMLITE LENS	Asahi Optical Co. C/O Rosati Associates, P.C.	1986-06-09	20
K861759	GIRARD SUNGLASSES (NON-PRESCRIPTION)	H. Girard S.A.	1986-06-09	34
K860794	WRAPPERS, SUNGLASSES	Mhci Corp.	1986-04-21	48
K860955	SPECTACLES LENS	Roseburg SA	1986-03-31	18
K854218	THE ULTRA-MATE LENS	Optical Systems Intl., Inc.	1985-11-12	26
K851410	O.M.S. UV-COLOURS	Optical Moulding Systems	1985-08-27	140
K852403	AURALITE II	Aura Lens Products	1985-08-20	75
K853110	SPECTACLE PRESCRIPTION LENSES	Ancie Laboratories	1985-08-09	16
K851163	SUNGLASES	Full See Glasses Ind. Co., Ltd.	1985-05-30	69
K850905	CR-39 TYPE RESIN	Orplex Corp.	1985-03-20	15
K844778	SUNGLASSES	B & M Sporting Goods, Inc.	1985-01-04	25
K842187	MULTIPLE LENS, SPECTACLES, CUSTOM	Pavuna , Ltd.	1984-12-11	190
K842189	MULTIPLE LENS, SPECTACLES CUSTOM	Hanmy Optical Industrial Co.	1984-12-11	190
K844321	CUSTOM LITE	Buchmann Optical Industries	1984-11-27	21
K843096	CRISTY/COTE	Titmus Optical, Inc.	1984-11-21	106
K841248	SUNGLASSES	China Toy & Novelty Co., Ltd.	1984-07-27	150
K833259	MULTIPLE	Sun House Products Co.	1984-04-02	195
K823825	NOSITE UV INTERIM SPECTACLES	Patton, Boggs & Blow	1983-02-24	66
K822573	SUNGLASS LENSES	ZEISS	1982-10-22	59
K821398	CORNING CPF 550 LENS	Corning Medical & Scientific	1982-06-25	45
K813130	SUNGLASSES	Panlin Corp.	1982-03-04	119
K812441	DI-CROWN	Coburn Optical Ind., Inc.	1981-10-06	41
K812051	PHOTOLITE AOLITE TINTOMATIC LENS	American Optical Corp.	1981-09-08	49
K811554	BARNES-HIND SPECTACLE LENS CLEANER	Barnes-Hind, Inc.	1981-07-02	30
K802749	BLENDED BIFOCAL	Robinson-Houchin, Inc.	1980-12-17	44
K802651	POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)	Chiron Vision Corp.	1980-12-17	54
K800521	THE LENS OR OMMI-GARD	Gentex Corporation	1980-03-12	6
K791901	BARNES-HIND WETTING & SOAKING SOLUTION	Barnes-Hind, Inc.	1979-11-16	52
K791721	ULTRAVUE BLENDED BIFOCAL LENS	American Optical Corp.	1979-10-23	54
K790215	LENS, POLYCORE	Polycore Optical Pte , Ltd.	1979-02-26	27
K790251	FUL-VUE ASPHERIC CATARACT LENS	American Optical Corp.	1979-02-26	20
K781927	HUMAN II LENS	Spectra-Shield, Inc.	1978-12-20	34

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