Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oculus Innovative Sciences, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
365 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102945 | PEDIACYN ATOPIC DERMATITIS HYDROGEL | Oculus Innovative Sciences, Inc. | 2011-02-02 | 121 | 0 |
| K093585 | MICROCYN SKIN AND WOUND HYDROGEL | Oculus Innovative Sciences, Inc. | 2010-03-08 | 109 | 1 |
| K090206 | OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER | Oculus Innovative Sciences, Inc. | 2009-06-02 | 125 | 3 |
| K090725 | OCULUS MICROCYN WOUND GEL | Oculus Innovative Sciences, Inc. | 2009-05-20 | 62 | 0 |
| K060113 | DERMACYN WOUND CARE | Oculus Innovative Sciences, Inc. | 2006-02-22 | 36 | 0 |
| K042729 | DERMACYN WOUND IRRIGATION | Oculus Innovative Sciences, Inc. | 2005-05-17 | 228 | 0 |
| K041161 | MICROCYN WOUND CARE DRESSING | Oculus Innovative Sciences, Inc. | 2005-05-03 | 365 | 2 |
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