Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Formatk Systems , 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) |
|---|---|---|---|---|---|
| K183307 | Magma Spark Pro (Magma Spark Plus, Alpha) | Formatk Systems , Ltd. | 2018-12-11 | 13 | 0 |
| K162781 | Magma Spark | Formatk Systems , Ltd. | 2016-11-09 | 37 | 0 |
| K160195 | Forma System, Forma Light System | Formatk Systems , Ltd. | 2016-04-15 | 79 | 0 |
| K153566 | Magma System | Formatk Systems , Ltd. | 2016-04-06 | 114 | 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