Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ototech, Ltd. — 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) |
|---|---|---|---|---|---|
| K910312 | C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID | Ototech, Ltd. | 1991-03-18 | 53 | 0 |
| K910313 | ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID | Ototech, Ltd. | 1991-03-18 | 53 | 0 |
| K910311 | ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID | Ototech, Ltd. | 1991-03-18 | 53 | 0 |
| K910314 | C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID | Ototech, Ltd. | 1991-03-18 | 53 | 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