Novabay Pharmaceuticals: FDA clearances and approvals
Novabay Pharmaceuticals has 5 FDA 510(k) clearances (first 2007, latest 2015), across 3 product codes in 2 review panels. Median 510(k) review time: 156 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 225 |
| 2013 | 1 | 56 |
| 2014 | 0 | — |
| 2015 | 1 | 156 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 3 | 3 |
| KMF | Bandage, Liquid | 1 | 1 |
| LRX | Case, Contact Lens | 1 | 1 |
Review panels
Most recent Novabay Pharmaceuticals 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143351 | iCase Contact Lens Case | LRX | 2015-04-29 | 156 |
| K131542 | NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC | FRO | 2013-07-24 | 56 |
| K113820 | NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER | FRO | 2012-08-08 | 225 |
| K081009 | NEUTROPHASE | KMF | 2008-05-20 | 42 |
| K071056 | NEUTROPHASE WOUND CLEANSER | FRO | 2007-09-28 | 165 |
Recalls
openFDA lists no recalls under a recalling firm named Novabay Pharmaceuticals.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Novabay Pharmaceuticals have?
Novabay Pharmaceuticals has 5 FDA 510(k) clearances (first 2007, latest 2015), across 3 product codes in 2 review panels.
How long does FDA take to clear Novabay Pharmaceuticals's 510(k)s?
The median time from FDA receipt to decision across Novabay Pharmaceuticals's cleared 510(k)s is 156 days.
What devices does Novabay Pharmaceuticals make?
Its most frequent FDA product codes are FRO (Dressing, Wound, Drug, 3); KMF (Bandage, Liquid, 1); LRX (Case, Contact Lens, 1).
Has Novabay Pharmaceuticals had device recalls?
openFDA lists no recalls under a recalling firm name matching Novabay Pharmaceuticals. Related entities may recall under other names.
Next steps
- See all 5 Novabay Pharmaceuticals clearances with predicates and recalls
- Run predicate analysis for product code FRO, Novabay Pharmaceuticals's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.