Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IWI — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
214 daysmedian FDA review time
304 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973363 | NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHE | Ml Strategies, Inc. | 1998-07-02 | 297 | 0 |
| K940632 | I-125 RAPID STRAND | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1994-09-02 | 200 | 0 |
| K912170 | RADIOACTIVE IODINE-125 SOURCES | Best Industries | 1991-08-09 | 85 | 0 |
| K882449 | CESIUM 137 SOURCE, MODEL CSM-40 | Cis-Us, Inc. | 1989-04-14 | 304 | 0 |
| K874787 | MODIFIED PALLADIUM SEED MODEL 100 | Theragenics Corp. | 1987-12-22 | 29 | 0 |
| K852542 | PALLADIUM SEED MODEL 100 | Nuclear Medicine, Inc. | 1986-01-14 | 214 | 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