Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fisma, Inc. — 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) |
|---|---|---|---|---|---|
| K000158 | VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 | Fisma, Inc. | 2000-08-24 | 218 | 0 |
| K991464 | DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 | Fisma, Inc. | 1999-07-20 | 84 | 0 |
| K990174 | ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, EL | Fisma, Inc. | 1999-04-01 | 72 | 0 |
| K963124 | PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) | Fisma, Inc. | 1996-11-08 | 88 | 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