Acudata Software: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Acudata Software” (first 1988, latest 1990), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 129 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 5 | 5 |
| GXY | Electrode, Cutaneous | 2 | 2 |
Review panels
- Neurology (7)
Most recent Acudata Software 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900668 | ACUDATA INDICATENS MODEL 5XS | GZJ | 1990-06-22 | 129 |
| K900596 | ACUDATA INDICATENS MODEL 5A | GZJ | 1990-06-22 | 134 |
| K890087 | ACUDATA INDICATENS MODEL 5M | GZJ | 1989-09-07 | 240 |
| K890088 | ACUDATA INDICATENS MODEL 5X | GZJ | 1989-05-26 | 136 |
| K891107 | INDICATENS INDICATOR ELECTRODE MODEL 2 | GXY | 1989-05-25 | 84 |
| K891105 | INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES | GXY | 1989-05-25 | 84 |
| K881708 | INDICATENS 4X4 | GZJ | 1988-08-11 | 113 |
Recalls
openFDA lists no recalls under a recalling firm named Acudata Software.
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 Acudata Software?
FDA lists 7 510(k) clearances under the applicant name “Acudata Software” (first 1988, latest 1990), 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 Acudata Software?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acudata Software is 129 days.
Which FDA product codes appear under Acudata Software?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 5); GXY (Electrode, Cutaneous, 2).
Next steps
- See all 7 Acudata Software clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Acudata Software'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.