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

Wesley Jessen Corp. — Predicate Candidate Screening

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

88 daysmedian FDA review time

147 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K994335	PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS	Wesley Jessen Corp.	2000-03-20	88
K000439	DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTAC	Wesley Jessen Corp.	2000-03-20	39
K993935	DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CON	Wesley Jessen Corp.	1999-12-21	32
K991000	GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES	Wesley Jessen Corp.	1999-06-28	96
K991550	FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERIC	Wesley Jessen Corp.	1999-05-14	10
K982988	PRECISION UV (VASURFILCON A)	Wesley Jessen Corp.	1999-01-06	133
K982344	DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONT	Wesley Jessen Corp.	1998-12-22	169
K965052	D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LEN	Wesley Jessen Corp.	1997-05-14	147
K962957	RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT	Wesley Jessen Corp.	1996-10-01	63
K954603	DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE T	Wesley Jessen Corp.	1996-01-04	92
K872973	W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION	Wesley Jessen Corp.	1987-10-15	77

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