Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Aktina Medical Corporation · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192102 | Thermoplastic Masks | Aktina Medical Corporation | 2019-09-25 | 51 | 0 |
| K161984 | Interlocked Circular Small Field Collimators, Elekta Integra | Aktina Medical Corporation | 2016-09-27 | 70 | 0 |
| K151097 | Active Breathing Coordinator | Aktina Medical Corporation | 2015-05-15 | 21 | 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