Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stargate International, 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) |
|---|---|---|---|---|---|
| K051631 | EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 | Stargate International, Inc. | 2005-07-27 | 37 | 0 |
| K041530 | EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 | Stargate International, Inc. | 2004-10-14 | 128 | 0 |
| K032816 | QUANTUM LIGHT THERAPY SYSTEM | Stargate International, Inc. | 2004-03-26 | 199 | 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