Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

HPC · Predicate Candidate Screening

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

70 daysmedian FDA review time

254 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K945443	BOBES LENS SET	Bobes S.A.	1995-07-19	254
K951437	OTI MODEL TLS-60	Oti Medical, LLC	1995-04-11	15
K930195	OPHTHALMIC TRIAL LENSES	Optimark Accessories and Instruments	1994-01-06	357
K934859	CONTACT LENSES	Arno Intl., Inc.	1993-12-21	70
K930446	MARCO TRIAL SETS	Marco Ophthalmic, Inc.	1993-07-06	161
K924786	BURTON TRIAL LENS SET	R.H. Burton Co.	1993-04-14	203
K920571	TRIAL LENS SET	R.H. Burton Co.	1992-05-07	90
K900478	WOODLYN FULL APERTURE TRIAL LENS SET	Woodlyn, Inc.	1990-02-21	20
K873907	CONFIRMATION TESTS	Richmond Products, Inc.	1987-12-29	95
K852056	ACC CROSS CYLINDERS	Ascon Medical Instruments, Ltd.	1985-06-05	27
K843095	TRIA LENS SET	Optek Medico Co., Ltd.	1984-10-05	59
K841766	WOODLYN CLASSIC TRIAL LENS SET	Woodlyn, Inc.	1984-06-01	35
K770389	LENS SET, MENTOR TRIAL	Codman & Shurtleff, Inc.	1977-03-14	14

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