Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Profound Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
447 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240296 | Tulsa Pro System (Pad-105) | Profound Medical, Inc. | 2024-05-09 | 98 | 0 |
| K230692 | TULSA-PRO System | Profound Medical, Inc. | 2023-09-20 | 191 | 0 |
| K211858 | TULSA-PRO System | Profound Medical, Inc. | 2022-09-06 | 447 | 0 |
| K202286 | Tulsa-Pro System | Profound Medical, Inc. | 2020-09-16 | 35 | 0 |
| K191200 | TULSA-PRO System | Profound Medical, Inc. | 2019-08-15 | 101 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda