Atlas FDA

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

HJI · Predicate Candidate Screening

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

74 daysmedian FDA review time
117 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K923670BYRNE EXPULSIVE LENSOcular Instruments, Inc.1992-11-161170
K90183960 FUNDUS CAMERA CF-60UVCanon USA, Inc.1990-07-05720
K902138STRIPE PROJECTORAcademic Catalyst Corp.1990-07-05560
K897186LASER IMAGING WORK STATIONInnovision Medical, Inc.1990-03-12740
K820223OMS QUARTZ INFUSION CONTACT LENSOptical Micro Systems, Inc.1982-02-0590
K802927SEBESTYEN IRRIGATING CONTACT LENSCooper Medical Devices Corp.1981-02-05780
K802971LANDERS CONTACT LENSCooper Medical Devices Corp.1981-02-05760
K760949CHARLES IRRIGATING FUNDUS CONTACT LENSRichard'S Medical Equip., Inc.1976-11-11100

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