Fortress Scientific , Ltd.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Fortress Scientific , Ltd.” (first 1989, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | 19 | 19 |
| INI | Vehicle, Motorized 3-Wheeled | 8 | 8 |
Review panels
- Physical Medicine (27)
Most recent Fortress Scientific , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933864 | 720 POWER BASE | ITI | 1994-03-28 | 234 |
| K933863 | S500 SEATING SYSTEM | ITI | 1994-03-28 | 234 |
| K933861 | S860 SEATING SYSTEM | ITI | 1994-03-28 | 234 |
| K933860 | S480 SEATING SYSTEM | ITI | 1994-03-28 | 234 |
| K933859 | SC930 SEAT CONTROLLER | ITI | 1994-03-28 | 234 |
| K933858 | 730 POWER BASE | ITI | 1994-03-28 | 234 |
| K933856 | A921 12 VOLT POWER SOCKET | ITI | 1994-03-28 | 234 |
| K933855 | S490 SEATING SYSTEM | ITI | 1994-03-28 | 234 |
| K933854 | 770 POWER BASE | ITI | 1994-03-28 | 234 |
| K933853 | A901 TILT IN SPACE | ITI | 1994-03-28 | 234 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fortress Scientific , Ltd..
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.
- Fortress Litestyle (8 510(k)s)
- Fortress Lite-Style Wheelchairs, Inc. (3 510(k)s)
- Fortress, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fortress Scientific , Ltd.?
FDA lists 27 510(k) clearances under the applicant name “Fortress Scientific , Ltd.” (first 1989, latest 1994), 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 Fortress Scientific , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fortress Scientific , Ltd. is 62 days.
Which FDA product codes appear under Fortress Scientific , Ltd.?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 19); INI (Vehicle, Motorized 3-Wheeled, 8).
Next steps
- See all 27 Fortress Scientific , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ITI, Fortress Scientific , Ltd.'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.