Output, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Output, Inc.” (first 1976, latest 1980), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| DSK | Computer, Blood-Pressure | 2 | 2 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 1 |
| DSF | Recorder, Paper Chart | 1 | 1 |
| GZI | Stimulator, Neuromuscular, External Functional | 1 | 1 |
Review panels
- Cardiovascular (3)
- Anesthesiology (1)
- Neurology (1)
Most recent Output, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800360 | OUTPUT DIGITAL DISPLAY MODULE, MOD. 611 | DSK | 1980-02-29 | 9 |
| K781115 | PRINTER, DIGITAL | DSF | 1978-10-06 | 95 |
| K780356 | OUTPUT DIGITAL DISPLAY MODULE, MODEL 401 | DSK | 1978-05-31 | 86 |
| K770987 | NERVE STIMULATOR, MOLEL NO. FB-800 | GZI | 1977-06-14 | 14 |
| K760614 | PERIPHERAL NERVE STIMULATOR | BXN | 1976-11-19 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Output, 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 Output, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Output, Inc.” (first 1976, latest 1980), across 4 product codes in 3 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 Output, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Output, Inc. is 70 days.
Which FDA product codes appear under Output, Inc.?
The most frequent FDA product codes under this applicant name are DSK (Computer, Blood-Pressure, 2); BXN (Stimulator, Nerve, Battery-Powered, 1); DSF (Recorder, Paper Chart, 1).
Next steps
- See all 5 Output, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSK, Output, 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 (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.