Atlas FDA

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

Oculus Innovative Sciences — Predicate Candidate Screening

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

122 daysmedian FDA review time
227 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K162217LOYONOculus Innovative Sciences2017-03-232270
K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences2016-08-191280
K153648Microcyn Plus Skin and Wound HydrogelOculus Innovative Sciences2016-04-191200
K152945Alevicyn SG Antipruritic GelOculus Innovative Sciences2015-12-15700
K152055Ceramax Skin Barrier CreamOculus Innovative Sciences2015-11-231221
K143590Alevicyn SG Antipruritic GelOculus Innovative Sciences2015-06-041680
K141352ENDOCYN ROOT CANAL IRRIGATION SOLUTIONOculus Innovative Sciences2014-08-18870
K141012HYDROCLEANSE WOUND CARE SOLUTIONOculus Innovative Sciences2014-08-081090
K131672MICROCYN SCAR MANAGEMENT HYDROGELOculus Innovative Sciences2013-11-151620

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