Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Magnatone Hearing Aid Corp. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
186 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973861 | FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 5 | Magnatone Hearing Aid Corp. | 1997-11-19 | 41 | 0 |
| K973665 | MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ | Magnatone Hearing Aid Corp. | 1997-11-04 | 40 | 0 |
| K944241 | MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID | Magnatone Hearing Aid Corp. | 1994-11-16 | 77 | 0 |
| K911183 | NHS 2044P BODY AID, HEARING AID | Magnatone Hearing Aid Corp. | 1991-07-09 | 113 | 0 |
| K911174 | NHS 2009SP HEARING AID | Magnatone Hearing Aid Corp. | 1991-05-09 | 52 | 0 |
| K911182 | NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS | Magnatone Hearing Aid Corp. | 1991-05-09 | 52 | 0 |
| K890525 | INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA | Magnatone Hearing Aid Corp. | 1989-05-19 | 106 | 0 |
| K852656 | MODEL M HEARING AID | Magnatone Hearing Aid Corp. | 1985-12-27 | 186 | 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