S & W Enterprises, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “S & W Enterprises, Inc.” (first 1983, latest 1987), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| INQ | Table, Powered | 3 | 3 |
| JFB | Table, Physical Therapy, Multi Function | 1 | 1 |
| KNC | Table, Obstetric (And Accessories) | 1 | 1 |
| LGX | Table, Examination, Medical, Powered | 1 | 1 |
Review panels
Most recent S & W Enterprises, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864817 | S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS | INQ | 1987-01-05 | 27 |
| K841145 | TILT TABLE 53 | INQ | 1984-04-13 | 28 |
| K832768 | S & W SW52E W/POWER BACK LIFT | LGX | 1983-09-20 | 35 |
| K830873 | S & W MODEL ASO | KNC | 1983-05-13 | 56 |
| K830875 | S & W MODEL 29 | JFB | 1983-04-08 | 21 |
| K830874 | S & W MODEL SW 37 | INQ | 1983-04-08 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named S & W Enterprises, 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 S & W Enterprises, Inc.?
FDA lists 6 510(k) clearances under the applicant name “S & W Enterprises, Inc.” (first 1983, latest 1987), 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 S & W Enterprises, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name S & W Enterprises, Inc. is 28 days.
Which FDA product codes appear under S & W Enterprises, Inc.?
The most frequent FDA product codes under this applicant name are INQ (Table, Powered, 3); JFB (Table, Physical Therapy, Multi Function, 1); KNC (Table, Obstetric (And Accessories), 1).
Next steps
- See all 6 S & W Enterprises, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INQ, S & W Enterprises, 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.