Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Proxima Therapeutics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
194 daysmedian FDA review time
340 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041929 | MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE | Proxima Therapeutics, Inc. | 2004-08-26 | 38 | 0 |
| K032067 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR | Proxima Therapeutics, Inc. | 2004-02-10 | 222 | 0 |
| K030558 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR | Proxima Therapeutics, Inc. | 2003-05-21 | 89 | 0 |
| K011690 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR | Proxima Therapeutics, Inc. | 2002-05-06 | 340 | 0 |
| K003206 | GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,104 | Proxima Therapeutics, Inc. | 2001-04-25 | 194 | 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