Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
North American Scientific, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062241 | ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR | North American Scientific, Inc. | 2006-11-09 | 99 | 0 |
| K060679 | SURTRAK IMPLANTATION KIT | North American Scientific, Inc. | 2006-04-21 | 37 | 0 |
| K052024 | NSTRAND IMPLANTATION KIT | North American Scientific, Inc. | 2005-09-07 | 43 | 0 |
| K964647 | NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTH | North American Scientific, Inc. | 1997-02-10 | 82 | 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