Prowess, Inc.: FDA clearances and approvals
Prowess, Inc. has 9 FDA 510(k) clearances (first 2003, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time: 116 days. Since 2017 its median was 133 days, against 113 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 116 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 365 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 133 |
| 2021 | 1 | 112 |
| 2022 | 0 | — |
| 2023 | 1 | 177 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Prowess, Inc.'s cleared 510(k)s took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | 6 | 6 |
| IYE | Accelerator, Linear, Medical | 3 | 3 |
Review panels
- Radiology (9)
Most recent Prowess, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231825 | Panther TPS | MUJ | 2023-12-15 | 177 |
| K211760 | Panther OIS | IYE | 2021-09-28 | 112 |
| K193459 | Panther Stereotactic | MUJ | 2020-04-27 | 133 |
| K143514 | Panther StereoSeed | MUJ | 2015-12-11 | 365 |
| K122616 | PANTHER OIS/R & V MODEL VERSION 2.0 | IYE | 2012-12-21 | 116 |
| K101076 | PROWESS PANTHER PROARC, MODEL VERSION 5.0 | MUJ | 2010-07-27 | 99 |
| K100801 | PUMA MODEL VERSION 1.0 | IYE | 2010-06-18 | 88 |
| K083502 | PANTHER REALART, MODEL 4.7 | MUJ | 2009-05-05 | 161 |
| K032456 | PROWESS | MUJ | 2003-10-16 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Prowess, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Prowess, Inc. have?
Prowess, Inc. has 9 FDA 510(k) clearances (first 2003, latest 2023), across 2 product codes in 1 review panel.
How long does FDA take to clear Prowess, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Prowess, Inc.'s cleared 510(k)s is 116 days. Since 2017: 133 days, versus 113 days for all cleared 510(k)s in the same product codes.
What devices does Prowess, Inc. make?
Its most frequent FDA product codes are MUJ (System, Planning, Radiation Therapy Treatment, 6); IYE (Accelerator, Linear, Medical, 3).
Has Prowess, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Prowess, Inc. Related entities may recall under other names.
Next steps
- See all 9 Prowess, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MUJ, Prowess, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.