Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Interacoustics A/S, Assens — 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) |
|---|---|---|---|---|---|
| K060539 | DPOAE20 , ECLIPSE | Interacoustics A/S, Assens | 2006-05-30 | 90 | 0 |
| K050496 | REM440 | Interacoustics A/S, Assens | 2005-04-29 | 60 | 0 |
| K030016 | TEOAE25 | Interacoustics A/S, Assens | 2003-03-28 | 85 | 0 |
| K022728 | AUDIOTRAVELLER, MODEL AA222 | Interacoustics A/S, Assens | 2002-10-11 | 56 | 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