Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biofourmis Singapore Pte., Ltd. · 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) |
|---|---|---|---|---|---|
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024-05-09 | 212 | 0 |
| K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023-02-23 | 440 | 0 |
| K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. | 2019-08-15 | 262 | 0 |
| K182344 | RhythmAnalytics | Biofourmis Singapore Pte., Ltd. | 2019-03-07 | 191 | 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