Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Interacoustics AS — 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) |
|---|---|---|---|---|---|
| K090406 | EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE | Interacoustics AS | 2009-07-22 | 155 | 0 |
| K083861 | TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITA | Interacoustics AS | 2009-04-09 | 106 | 0 |
| K052562 | ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF | Interacoustics AS | 2005-12-23 | 95 | 0 |
| K043219 | AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION O | Interacoustics AS | 2005-02-04 | 74 | 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