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

Vistakon, Johnson & Johnson Vision Products, Inc. · Predicate Candidate Screening

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

63 daysmedian FDA review time

84 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K994318	VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR A	Vistakon, Johnson & Johnson Vision Products, Inc.	2000-02-23	63
K994324	ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR A	Vistakon, Johnson & Johnson Vision Products, Inc.	2000-02-23	63
K991163	VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, C	Vistakon, Johnson & Johnson Vision Products, Inc.	1999-06-08	62
K991134	ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR	Vistakon, Johnson & Johnson Vision Products, Inc.	1999-05-06	34
K983912	VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TIN	Vistakon, Johnson & Johnson Vision Products, Inc.	1999-01-26	84
K964612	VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILI	Vistakon, Johnson & Johnson Vision Products, Inc.	1997-01-30	73
K962804	ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT	Vistakon, Johnson & Johnson Vision Products, Inc.	1996-10-01	75
K953804	VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS	Vistakon, Johnson & Johnson Vision Products, Inc.	1995-09-26	49

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