Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IWL · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063691 | NEUTRON THERAPY SYSTEM | Northern Illinois Univ. Outreach | 2007-01-31 | 50 | 0 |
| K852804 | MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS | Medcyc. Corp. | 1985-10-15 | 104 | 0 |
| K812337 | ISOCENTRIC NEUTRON THERAPY SYSTEMS | The Cyclotron Corp. | 1981-10-02 | 45 | 0 |
| K811778 | MODEL 4100 14 MEV NEUTRON GEN. THERAPY | The Cyclotron Corp. | 1981-07-23 | 30 | 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