Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Therapanacea Sas — 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) |
|---|---|---|---|---|---|
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 2025-12-23 | 91 | 0 |
| K242822 | ART-Plan+ (v.3.0.0) | Therapanacea Sas | 2025-02-25 | 160 | 0 |
| K234068 | ART-Plan (v.2.2.0) | Therapanacea Sas | 2024-04-22 | 122 | 0 |
| K230023 | ART-Plan | Therapanacea Sas | 2023-04-19 | 105 | 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