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Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Optus, Inc. — Predicate Candidate Screening

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

207 daysmedian FDA review time
462 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K945264OPTUS OTOSCOPESOptus, Inc.1996-02-024620
K953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIESOptus, Inc.1996-01-221540
K945268OPTUS BRONCHOSCOPESOptus, Inc.1995-12-214190
K945265OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPESOptus, Inc.1995-09-123190
K945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESOptus, Inc.1995-05-262100
K945267OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPESOptus, Inc.1995-05-232070
K945266OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPESOptus, Inc.1995-02-231180
K944656OPTUS SINUSCOPES AND ACCESSORIESOptus, Inc.1995-01-261270
K945263OPTUS THORACOSCOPESOptus, Inc.1994-12-13460
K945269OPTUS LARYNGOSCOPESOptus, Inc.1994-11-07100

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