Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
W&H Sterilization S.R.L. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233504 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | 2024-02-08 | 100 | 0 |
| K223858 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | 2023-05-05 | 133 | 0 |
| K213758 | Lexa PLUS RIS-311 | W&H Sterilization S.R.L. | 2022-08-19 | 262 | 0 |
| K172825 | MN-111 | W&H Sterilization S.R.L. | 2018-05-30 | 254 | 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