Atlas FDA

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

Oculus Optikgeräte GmbH — Predicate Candidate Screening

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

270 daysmedian FDA review time
388 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH2026-03-132700
K202989Myopia MasterOculus Optikgeräte GmbH2021-07-142871
K201724Pentacam AXL WaveOculus Optikgerate GmbH2020-10-211201
K152311Pentacam AXLOculus Optikgerate GmbH2016-01-201591
K113066CORVIS STOculus Optikgerate GmbH2012-11-083880
K073508PARKONEOculus Optikgerate GmbH2008-09-112730
K041841PACHYCAMOculus Optikgerate GmbH2005-01-282040
K030719PENTACAM SCHEIMPFLUG CAMERAOculus Optikgerate GmbH2003-09-161930

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