Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ml Strategies, 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) |
|---|---|---|---|---|---|
| K983401 | FRAMEWAVE WEB | Ml Strategies, Inc. | 1998-12-15 | 78 | 0 |
| K973363 | NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHE | Ml Strategies, Inc. | 1998-07-02 | 297 | 0 |
| K972271 | NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTH | Ml Strategies, Inc. | 1997-10-28 | 132 | 0 |
| K950354 | HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY | Ml Strategies, Inc. | 1995-07-19 | 170 | 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