Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dyna-Med — 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) |
|---|---|---|---|---|---|
| K884578 | POLARIX 2 AND POLARIX 2E | Dyna-Med | 1989-02-09 | 100 | 0 |
| K884340 | AMX-110, AMX-II AND AMX-III | Dyna-Med | 1989-01-24 | 102 | 0 |
| K863504 | OBSTETRICAL KIT | Dyna-Med | 1986-10-22 | 43 | 0 |
| K760258 | BITE STICK, DYNA | Dyna-Med | 1976-07-26 | 6 | 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