Profound Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Profound Medical, Inc.” (first 2019, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 101 days. Since 2017 the median was 101 days, against 144 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2019 | 1 | 101 |
| 2020 | 1 | 35 |
| 2021 | 0 | — |
| 2022 | 1 | 447 |
| 2023 | 1 | 191 |
| 2024 | 1 | 98 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Profound Medical, Inc. took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 5 | 5 |
Review panels
Most recent Profound Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240296 | Tulsa Pro System (Pad-105) | PLP | 2024-05-09 | 98 |
| K230692 | TULSA-PRO System | PLP | 2023-09-20 | 191 |
| K211858 | TULSA-PRO System | PLP | 2022-09-06 | 447 |
| K202286 | Tulsa-Pro System | PLP | 2020-09-16 | 35 |
| K191200 | TULSA-PRO System | PLP | 2019-08-15 | 101 |
Recalls
openFDA lists no recalls under a recalling firm named Profound Medical, 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.
SEC filings
Profound Medical Corp. (PROF): EDGAR filings, CIK 1628808. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Profound Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Profound Medical, Inc.” (first 2019, latest 2024), across 1 product code 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 Profound Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Profound Medical, Inc. is 101 days. Since 2017: 101 days, versus 144 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Profound Medical, Inc.?
The most frequent FDA product codes under this applicant name are PLP (High Intensity Ultrasound System For Prostate Tissue Ablation, 5).
Next steps
- See all 5 Profound Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PLP, Profound Medical, 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.