Atlas FDA

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

LYX — Predicate Candidate Screening

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

79 daysmedian FDA review time
212 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251320XTRA4Al.Chi.Mi.A. S.R.L2025-09-111350
K221759CornisolAurolab2022-10-051100
K211786Independent Corneal Viewing Chamber (IVC-21)Bausch + Lomb, Incorporated2021-12-031770
K162013Eusol-CAl.Chi.Mi.A. S.R.L2016-09-15560
K151061Cornea ColdEurobio2015-08-061080
K063304LIFE4CNumedis, Inc.2007-12-214150
K063617EUSOL-CAl.Chi.Mi.A2007-02-08650
K032422EUSOL-CAl.Chi.Mi.A2003-12-151320
K954548THE CHEN MEDIUMChen Ophthalmic Laboratories1996-05-202310
K924165OPTISOL-GS CORNEAL STORAGE MEDIAChiron Intraoptics1992-10-06480
K921729OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIEDChiron Intraoptics1992-06-09760
K921728DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIEDChiron Intraoptics1992-06-09760
K894162OPTISOLChiron Ophthalmics1990-01-122120
K883854DEXSOLNorthern Scientific, Inc.1988-11-16640
K870249MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUMBioclinical Laboratory Services, Inc.1987-04-06750
K870250MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUMBioclinical Laboratory Services, Inc.1987-04-06750
K870251CHONDROITIN SULFATE CORNEAL STORAGE MEDIUMBioclinical Laboratory Services, Inc.1987-04-06750
K8631293M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM)3M Company1986-09-17330
K854052CSM MEDIUMNorthern Scientific, Inc.1985-12-31890
K844249K-SOLCilco, Inc.1985-04-301790
K821170CORNEA PERSERVATION UNITXytex Corp.1982-07-14790

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