Hc Electronics: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Hc Electronics” (first 1977, latest 1981), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 12 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 | 5 | 5 |
| EPF | Hearing Aid, Group And Auditory Trainer | 3 | 3 |
Plus 1 more product codes.
Review panels
Most recent Hc Electronics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K810031 | STEREO AUDITORY TRAINER (MODEL PM228) | EPF | 1981-03-04 | 57 |
| K810030 | POST-AURICULAR HEARING AID (#PE830) | ESD | 1981-01-14 | 8 |
| K800340 | PHONIC EAR, MODEL 841L | ESD | 1980-02-26 | 11 |
| K782053 | HEARING AID, POST-AURICULAR | ESD | 1978-12-15 | 8 |
| K780936 | PHONIC EAR | EPF | 1978-06-22 | 14 |
| K780363 | PHONIC EAR | ESD | 1978-03-21 | 15 |
| K772347 | PHONIC MIRROR HANDIVOICE MODEL 120 | — | 1978-01-11 | 19 |
| K772346 | PHONIC MIRROR HANDIVOCIE MODEL 110 | — | 1978-01-11 | 19 |
| K771357 | GROUP AUDITORY TRAINER HC 431R | EPF | 1977-07-29 | 7 |
| K771356 | POST-AURICULAR HEARING AID HC 880 | ESD | 1977-07-29 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Hc Electronics.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hc Electronics?
FDA lists 10 510(k) clearances under the applicant name “Hc Electronics” (first 1977, latest 1981), across 3 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 Hc Electronics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hc Electronics is 12 days.
Which FDA product codes appear under Hc Electronics?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 5); EPF (Hearing Aid, Group And Auditory Trainer, 3).
Next steps
- See all 10 Hc Electronics clearances with predicates and recalls
- Run predicate analysis for product code ESD, Hc Electronics'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.