Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Otodynamics, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
162 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240430 | Otoport Pro | Otodynamics, Ltd. | 2024-03-15 | 30 | 0 |
| K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE | Otodynamics, Ltd. | 2015-02-23 | 89 | 0 |
| K072033 | OTODYNAMICS OTOPORT | Otodynamics, Ltd. | 2007-11-13 | 112 | 0 |
| K983351 | ILO292 DP ECHOPORT PLUS OAE SYSTEM | Otodynamics, Ltd. | 1998-12-11 | 79 | 0 |
| K983350 | ILO292 DP ECHOPORT PLUS OAE SYSTEM | Otodynamics, Ltd. | 1998-12-11 | 79 | 0 |
| K983352 | ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK | Otodynamics, Ltd. | 1998-12-11 | 79 | 0 |
| K962995 | ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC | Otodynamics, Ltd. | 1997-01-10 | 162 | 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