Marcon Hearing Instruments, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Marcon Hearing Instruments, Inc.” (first 1979, latest 1982), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 21 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 9 | 9 |
Plus 1 more product codes.
Review panels
Most recent Marcon Hearing Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823468 | MODEL H 37E | ESD | 1982-12-03 | 11 |
| K821042 | MODEL IM9 | ESD | 1982-05-05 | 21 |
| K791745 | MODEL H44-80 BEHIND THE EAR HEARING | ESD | 1979-10-30 | 50 |
| K791126 | MODEL CE-DM-II HEARING INSTRUMENT | ESD | 1979-07-17 | 29 |
| K790870 | MODEL H63, BEHIND-THE-EAR | ESD | 1979-07-05 | 59 |
| K790779 | MODEL H39C-BEHING-THE-EAR HEARING INSTRU | — | 1979-05-16 | 23 |
| K790727 | BEHIND-THE-EAR, MODEL H37D | ESD | 1979-05-01 | 18 |
| K790726 | BEHIND-THE-EAR HEARING INSTRUMENT, H54 | ESD | 1979-05-01 | 18 |
| K790700 | BEHIND-THE-EAR HEARING INSTRUMENT, H56 | ESD | 1979-05-01 | 19 |
| K790697 | MODEL H58-BEHIND-THE-EAR HEARING INSTR. | ESD | 1979-05-01 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Marcon Hearing Instruments, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Marcon Group, Inc. (1 510(k)s)
- Marcon Rubber Industry Sdn. Bhd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Marcon Hearing Instruments, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Marcon Hearing Instruments, Inc.” (first 1979, latest 1982), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Marcon Hearing Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Marcon Hearing Instruments, Inc. is 21 days.
Which FDA product codes appear under Marcon Hearing Instruments, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 9).
Next steps
- See all 10 Marcon Hearing Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Marcon Hearing Instruments, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.