Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Caf Medical Solutions, Inc. · 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) |
|---|---|---|---|---|---|
| K221879 | Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 | Caf Medical Solutions, Inc. | 2022-08-10 | 43 | 0 |
| K221616 | Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 | Caf Medical Solutions, Inc. | 2022-08-01 | 59 | 0 |
| K220362 | LE-12CH | Caf Medical Solutions, Inc. | 2022-03-25 | 45 | 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