Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Phantom Laboratory, 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) |
|---|---|---|---|---|---|
| K082909 | RSVP HALF SPHERE PHANTOM, MODEL DDP010 | The Phantom Laboratory, Inc. | 2008-12-23 | 84 | 0 |
| K081760 | RSVP PHANTOM PELVIS, MODEL TLP260 | The Phantom Laboratory, Inc. | 2008-07-29 | 39 | 0 |
| K002840 | MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM | The Phantom Laboratory, Inc. | 2000-11-17 | 66 | 0 |
| K954634 | RADIOSURGERY VERIFICATION PHANTOM | The Phantom Laboratory, Inc. | 1995-12-22 | 77 | 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