Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Marcon Hearing Instruments, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
59 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823468 | MODEL H 37E | Marcon Hearing Instruments, Inc. | 1982-12-03 | 11 | 0 |
| K821042 | MODEL IM9 | Marcon Hearing Instruments, Inc. | 1982-05-05 | 21 | 0 |
| K791745 | MODEL H44-80 BEHIND THE EAR HEARING | Marcon Hearing Instruments, Inc. | 1979-10-30 | 50 | 0 |
| K791126 | MODEL CE-DM-II HEARING INSTRUMENT | Marcon Hearing Instruments, Inc. | 1979-07-17 | 29 | 0 |
| K790870 | MODEL H63, BEHIND-THE-EAR | Marcon Hearing Instruments, Inc. | 1979-07-05 | 59 | 0 |
| K790779 | MODEL H39C-BEHING-THE-EAR HEARING INSTRU | Marcon Hearing Instruments, Inc. | 1979-05-16 | 23 | 0 |
| K790727 | BEHIND-THE-EAR, MODEL H37D | Marcon Hearing Instruments, Inc. | 1979-05-01 | 18 | 0 |
| K790697 | MODEL H58-BEHIND-THE-EAR HEARING INSTR. | Marcon Hearing Instruments, Inc. | 1979-05-01 | 21 | 0 |
| K790700 | BEHIND-THE-EAR HEARING INSTRUMENT, H56 | Marcon Hearing Instruments, Inc. | 1979-05-01 | 19 | 0 |
| K790726 | BEHIND-THE-EAR HEARING INSTRUMENT, H54 | Marcon Hearing Instruments, Inc. | 1979-05-01 | 18 | 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