Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Theragenics Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
86 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103319 | I-SEED | Theragenics Corp. | 2011-01-03 | 52 | 0 |
| K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 | Theragenics Corp. | 2007-09-26 | 40 | 1 |
| K043596 | THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 | Theragenics Corp. | 2005-01-26 | 28 | 0 |
| K010283 | THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 | Theragenics Corp. | 2001-04-26 | 86 | 0 |
| K874787 | MODIFIED PALLADIUM SEED MODEL 100 | Theragenics Corp. | 1987-12-22 | 29 | 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