Rochal Industries, LLC: FDA clearances and approvals
Rochal Industries, LLC has 5 FDA 510(k) clearances (first 2016, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time: 155 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 3 | 155 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 272 |
| 2020 | 1 | 147 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Rochal Industries, LLC's cleared 510(k)s took a median 210 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 3 | 3 |
| KMF | Bandage, Liquid | 2 | 2 |
Review panels
Most recent Rochal Industries, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192527 | Rochal Antimicrobial Wound Gel | FRO | 2020-02-07 | 147 |
| K182733 | Rochal Bioshield Silicone Film | KMF | 2019-06-27 | 272 |
| K161212 | Atteris Antimicrobial Skin Protectant | FRO | 2016-09-30 | 155 |
| K160192 | Atteris Antimicrobial Skin & Wound Cleanser | FRO | 2016-07-28 | 183 |
| K160684 | Atteris No-Sting Skin Protectant | KMF | 2016-07-26 | 137 |
Recalls
openFDA lists no recalls under a recalling firm named Rochal Industries, LLC.
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 Rochal Industries, LLC have?
Rochal Industries, LLC has 5 FDA 510(k) clearances (first 2016, latest 2020), across 2 product codes in 1 review panel.
How long does FDA take to clear Rochal Industries, LLC's 510(k)s?
The median time from FDA receipt to decision across Rochal Industries, LLC's cleared 510(k)s is 155 days.
What devices does Rochal Industries, LLC make?
Its most frequent FDA product codes are FRO (Dressing, Wound, Drug, 3); KMF (Bandage, Liquid, 2).
Has Rochal Industries, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Rochal Industries, LLC. Related entities may recall under other names.
Next steps
- See all 5 Rochal Industries, LLC clearances with predicates and recalls
- Run predicate analysis for product code FRO, Rochal Industries, LLC'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.