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

Coburn Optical Ind., Inc. · Predicate Candidate Screening

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

51 daysmedian FDA review time
73 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K892351MAGNILINK SYSTEM 602Coburn Optical Ind., Inc.1989-05-26510
K892347MAGNILINK SYSTEM 101Coburn Optical Ind., Inc.1989-05-26510
K892348MAGNILINK SYSTEM 201Coburn Optical Ind., Inc.1989-05-26510
K892350MAGNILINK SYSTEM 402/5Coburn Optical Ind., Inc.1989-05-26510
K892349MAGNILINK SYSTEM 209Coburn Optical Ind., Inc.1989-05-26510
K862188IRRIGATION & ASPIRATION/VITRECTOMY DEVICECoburn Optical Ind., Inc.1986-08-21730
K853457COBURN I/A SYSTEMCoburn Optical Ind., Inc.1985-10-15600
K821737DISP. MICROSURGICAL KNIVESCoburn Optical Ind., Inc.1982-07-02180
K812441DI-CROWNCoburn Optical Ind., Inc.1981-10-06410
K803159AUTOMATED PERIMETERSCoburn Optical Ind., Inc.1981-02-04580
K801659BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPECoburn Optical Ind., Inc.1980-09-09500
K801231EYE-VACCoburn Optical Ind., Inc.1980-07-21550
K791659MEDITEC (RODENSTOCK) LASER PHOTOCOAGULCoburn Optical Ind., Inc.1979-10-11500
K781507RETINOMETERCoburn Optical Ind., Inc.1978-11-15750

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