Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioserenity Sas — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231366 | Neuronaute Plus | Bioserenity Sas | 2023-11-09 | 182 | 0 |
| K202334 | Neuronaute | Bioserenity Sas | 2020-12-10 | 115 | 0 |
| K173248 | CARDIOSKIN | Bioserenity Sas | 2018-08-11 | 305 | 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