Atlas FDA

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

Fci Ophthalmics, Inc. · Predicate Candidate Screening

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

87 daysmedian FDA review time
313 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K061404MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICEFci Ophthalmics, Inc.2006-08-07800
K061398SNUG PLUG PUNCTUM PLUGFci Ophthalmics, Inc.2006-07-11530
K041869SELF RETAINING BICANALICULUS INTUBATION SETFci Ophthalmics, Inc.2004-11-181320
K023758BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)Fci Ophthalmics, Inc.2003-09-173130
K023400FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANTFci Ophthalmics, Inc.2003-08-223170
K030054DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSESFci Ophthalmics, Inc.2003-02-26510
K992294BIOCERAMIC ORBITAL IMPLANTFci Ophthalmics, Inc.2000-04-192870
K991238FCI CRAWFORD PROBE INTUBATION SETSFci Ophthalmics, Inc.1999-07-08870
K980816RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS)Fci Ophthalmics, Inc.1998-09-181990
K980822TITANIUM PEG SYSTEMFci Ophthalmics, Inc.1998-07-091280
K964774PUNCTUM PLUGS & READY-SET PUNCTAL PLUGSFci Ophthalmics, Inc.1996-12-20590
K963219RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, Fci Ophthalmics, Inc.1996-10-28730
K961909READY-SET PUNCTAL PLUGSFci Ophthalmics, Inc.1996-07-25700

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