Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IWA · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
195 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K915253 | IR-192 IMPLANT, MODIFICATION | Omnitron Intl., Inc. | 1992-02-27 | 101 | 0 |
| K894409 | CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD | Amersham Corp. | 1989-09-29 | 74 | 0 |
| K874895 | IR-192 IMPLANT | Rads S.L., Inc. | 1988-02-25 | 86 | 0 |
| K850382 | IRIDIUM SEEDS | Radiation Safety & Nuclear Products, Inc. | 1985-08-15 | 195 | 0 |
| K844248 | IR-192 IMPLANT | Rads S.L., Inc. | 1985-04-10 | 159 | 0 |
| K850726 | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD | Syncor Intl. Corp. | 1985-03-26 | 32 | 0 |
| K850163 | IRIDIUM 192 WIRES | Syncor Intl. Corp. | 1985-03-26 | 69 | 0 |
| K771878 | IRIDIUM 192 WIRES & PINS | Cis Radiopharmaceuticals, Inc. | 1977-10-27 | 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