Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Specialty Ultravision, Inc. · Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time

196 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K011542	SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS	Specialty Ultravision, Inc.	2001-06-26	39
K011089	SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LEN	Specialty Ultravision, Inc.	2001-05-23	43
K003789	SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LE	Specialty Ultravision, Inc.	2001-02-21	75
K003526	SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT L	Specialty Ultravision, Inc.	2001-02-12	88
K000376	SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY	Specialty Ultravision, Inc.	2000-03-21	43
K993580	SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS	Specialty Ultravision, Inc.	2000-02-02	103
K992787	EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DA	Specialty Ultravision, Inc.	2000-02-02	167
K984090	SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC)	Specialty Ultravision, Inc.	1999-07-07	233
K980197	ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAI	Specialty Ultravision, Inc.	1998-08-04	196
K973192	FLEXLENS, FLEXLENS TORIC	Specialty Ultravision, Inc.	1997-11-20	87
K963764	SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR	Specialty Ultravision, Inc.	1997-01-30	133
K963488	SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHI	Specialty Ultravision, Inc.	1996-11-20	78

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