Focus Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Focus Technologies, Inc.” (first 2002, latest 2004), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| NOP | Elisa, Antibody, West Nile Virus | 3 | 3 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | 2 |
Review panels
- Microbiology (5)
Most recent Focus Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040854 | WEST NILE VIRUS IGM CAPTURE ELISA | NOP | 2004-06-30 | 90 |
| K031953 | WEST NILE VIRUS ELISA IGG, MODEL EL0300G | NOP | 2003-10-22 | 119 |
| K031952 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M | NOP | 2003-10-22 | 119 |
| K021486 | HERPESELECT 2 ELISA IGG, MODEL ELO920G | MXJ | 2002-08-01 | 90 |
| K021429 | HERPESELECT 1 ELISA IGG, MODEL EL0910G | MXJ | 2002-07-29 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Focus Technologies, 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.
- Focus Diagnostics, Inc. (16 510(k)s)
- Focus Medical, LLC (9 510(k)s)
- Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC (1 510(k)s)
- Focus International, Inc. (1 510(k)s)
- Focus Medical SA (1 510(k)s)
- Focus Surgery, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Focus Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Focus Technologies, Inc.” (first 2002, latest 2004), 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 Focus Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Focus Technologies, Inc. is 90 days.
Which FDA product codes appear under Focus Technologies, Inc.?
The most frequent FDA product codes under this applicant name are NOP (Elisa, Antibody, West Nile Virus, 3); MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1, 2).
Next steps
- See all 5 Focus Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NOP, Focus Technologies, 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.