Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Isoray, 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) |
|---|---|---|---|---|---|
| K132996 | CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE | Isoray, Inc. | 2013-12-17 | 84 | 0 |
| K062384 | CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE | Isoray, Inc. | 2006-11-09 | 86 | 0 |
| K030162 | LAWRENCE CSERION, MODEL CS-1 | Isoray, Inc. | 2003-03-28 | 71 | 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