Dahlberg Electronics, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Dahlberg Electronics, Inc.” (first 1979, latest 1990), across 1 product code in 1 review panel. Median 510(k) review time under this name: 29 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 | 31 | 31 |
Review panels
- Ear, Nose and Throat (31)
Most recent Dahlberg Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896159 | DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID | ESD | 1990-01-22 | 90 |
| K896158 | DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AID | ESD | 1990-01-22 | 90 |
| K896157 | DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID | ESD | 1990-01-22 | 90 |
| K881417 | DAHLBERG MODEL GP BODY AID | ESD | 1988-06-07 | 64 |
| K881612 | DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID | ESD | 1988-06-01 | 50 |
| K874831 | AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID | ESD | 1988-02-22 | 90 |
| K874830 | MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID | ESD | 1988-02-17 | 85 |
| K873169 | DAHLBERG MODEL GH BODY AID | ESD | 1987-09-16 | 36 |
| K873397 | DAHLBERG MODEL MH BEHIND-THE-EAR HEARING AID | ESD | 1987-09-14 | 21 |
| K873376 | MODEL SI AND SP BEHIND-THE-EAR HEARING AID | ESD | 1987-09-14 | 21 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dahlberg Electronics, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dahlberg Electronics, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Dahlberg Electronics, Inc.” (first 1979, latest 1990), across 1 product code 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 Dahlberg Electronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dahlberg Electronics, Inc. is 29 days.
Which FDA product codes appear under Dahlberg Electronics, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 31).
Next steps
- See all 31 Dahlberg Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Dahlberg Electronics, 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.