Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rochal Industries, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
155 daysmedian FDA review time
272 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192527 | Rochal Antimicrobial Wound Gel | Rochal Industries, LLC | 2020-02-07 | 147 | 0 |
| K182733 | Rochal Bioshield Silicone Film | Rochal Industries, LLC | 2019-06-27 | 272 | 0 |
| K161212 | Atteris Antimicrobial Skin Protectant | Rochal Industries, LLC | 2016-09-30 | 155 | 0 |
| K160192 | Atteris Antimicrobial Skin & Wound Cleanser | Rochal Industries, LLC | 2016-07-28 | 183 | 0 |
| K160684 | Atteris No-Sting Skin Protectant | Rochal Industries, LLC | 2016-07-26 | 137 | 0 |
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