American Electromedics Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “American Electromedics Corp.” (first 1982, latest 1998), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| ETY | Tester, Auditory Impedance | 12 | 12 |
| EWO | Audiometer | 6 | 6 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ear, Nose and Throat (18)
- Anesthesiology (1)
Most recent American Electromedics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983051 | AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | ETY | 1998-11-18 | 78 |
| K983049 | AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER | ETY | 1998-11-18 | 78 |
| K983048 | AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | EWO | 1998-11-17 | 77 |
| K983046 | AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER | ETY | 1998-11-17 | 77 |
| K972221 | K 15 AUDIOMETER | EWO | 1997-09-08 | 87 |
| K970279 | RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) | EWO | 1997-03-18 | 54 |
| K955289 | RACE CAR TYMPANOMETER | ETY | 1995-12-08 | 22 |
| K951527 | THE PILOT AUDIOMETER | EWO | 1995-05-03 | 30 |
| K930164 | THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S | ETY | 1993-04-23 | 100 |
| K924934 | AUTOMATIC IMPEDANCE METER AE-205 | ETY | 1993-01-21 | 113 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Electromedics Corp..
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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Electromedics Corp.?
FDA lists 20 510(k) clearances under the applicant name “American Electromedics Corp.” (first 1982, latest 1998), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by American Electromedics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Electromedics Corp. is 89 days.
Which FDA product codes appear under American Electromedics Corp.?
The most frequent FDA product codes under this applicant name are ETY (Tester, Auditory Impedance, 12); EWO (Audiometer, 6); BZG (Spirometer, Diagnostic, 1).
Next steps
- See all 20 American Electromedics Corp. clearances with predicates and recalls
- Run predicate analysis for product code ETY, American Electromedics Corp.'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.