Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Idem (Int'L Dist. of Electronics For Medicine) · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
146 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991853 | INTERACOUSTICS EP 15 ABR STAND ALONE UNIT | Idem (Int'L Dist. of Electronics For Medicine) | 1999-10-25 | 146 | 0 |
| K990585 | INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1999-05-17 | 83 | 0 |
| K990652 | INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1999-05-17 | 77 | 0 |
| K983832 | INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1999-01-25 | 87 | 0 |
| K982249 | INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1998-08-07 | 42 | 0 |
| K981327 | INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | 1998-05-11 | 28 | 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