Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Isoray Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
142 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI | Isoray Medical, Inc. | 2020-12-31 | 142 | 0 |
| K180515 | GammaTile | Isoray Medical, Inc. | 2018-07-06 | 129 | 0 |
| K111931 | GLIASITE RTS | Isoray Medical, Inc. | 2011-08-05 | 28 | 0 |
| K092458 | PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS- | Isoray Medical, Inc. | 2009-08-28 | 17 | 0 |
| K092136 | PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 | Isoray Medical, Inc. | 2009-08-07 | 23 | 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