Atlas FDA

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

Eagle Vision, Inc. — Predicate Candidate Screening

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

81 daysmedian FDA review time
184 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K053333EAGLEVISION GELLANSERTS, MODEL REF 0040Eagle Vision, Inc.2006-05-021520
K030353MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETSEagle Vision, Inc.2003-04-25810
K991130FLEXPLUGEagle Vision, Inc.1999-04-20180
K905427EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUGEagle Vision, Inc.1991-06-061840
K890919TEMPORARY INTRACANALICULAR COLLAGEN IMPLANTEagle Vision, Inc.1989-05-16820
K890920EAGLE VISION-FREEMAN(TM) PUNCTAL VALVEEagle Vision, Inc.1989-04-11470
K883233EV MONOCANALICULAR STENT (TM)Eagle Vision, Inc.1988-08-22210

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