Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IWG — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081066 | BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 | Medi-Physics, Inc., Dba GE Healthcare | 2008-05-05 | 20 | 0 |
| K982421 | IMAGYN 125 I SEED, MODEL IS 125 | International Isotopes, Inc. | 1998-07-31 | 18 | 0 |
| K834027 | GOLD SEADS | Radiation Safety & Nuclear Products, Inc. | 1983-12-27 | 35 | 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