Amplaid USA, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Amplaid USA, Inc.” (first 1978, latest 1986), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | 3 | 3 |
| ETY | Tester, Auditory Impedance | 1 | 1 |
| EWO | Audiometer | 1 | 1 |
| GWE | Stimulator, Photic, Evoked Response | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| GWL | Amplifier, Physiological Signal | 1 | 1 |
Review panels
- Neurology (6)
- Ear, Nose and Throat (2)
Most recent Amplaid USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861014 | AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) | GWL | 1986-08-20 | 155 |
| K832510 | EVOKED POTENTIALS SYSTEM MK10 | GWJ | 1983-11-25 | 121 |
| K810482 | SOMATOSENSORY STIMULATOR | GWF | 1981-04-29 | 65 |
| K810473 | MK6 ERA SYSTEM | GWJ | 1981-04-29 | 65 |
| K810481 | VISUAL PATTERN REVERSAL GEN. & PHOTIC S. | GWE | 1981-03-11 | 16 |
| K802963 | 101, 151, 161 PORTABLE AUDIOMETERS | EWO | 1980-12-19 | 28 |
| K802097 | SELF-RECORDING ADMITTANCE METER 709 | ETY | 1980-10-10 | 38 |
| K781667 | AMPLAID MARK 4 AND MARK 5 | GWJ | 1978-11-03 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Amplaid USA, 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.
- Amplaid (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Amplaid USA, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Amplaid USA, Inc.” (first 1978, latest 1986), across 6 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 Amplaid USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amplaid USA, Inc. is 52 days.
Which FDA product codes appear under Amplaid USA, Inc.?
The most frequent FDA product codes under this applicant name are GWJ (Stimulator, Auditory, Evoked Response, 3); ETY (Tester, Auditory Impedance, 1); EWO (Audiometer, 1).
Next steps
- See all 8 Amplaid USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWJ, Amplaid USA, 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.