Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PLP — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
152 daysmedian FDA review time
272 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251910 | Focal One® | Edap Technomed, Inc. | 2025-11-19 | 152 | 0 |
| K240296 | Tulsa Pro System (Pad-105) | Profound Medical, Inc. | 2024-05-09 | 98 | 0 |
| K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MR | Insightec, Ltd. | 2023-10-30 | 171 | 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 |
| K212150 | Exablate Prostate System | Insightec, Inc. | 2021-11-23 | 137 | 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 |
| K172721 | FOCAL ONE | Edap Technomed, Inc. | 2018-06-07 | 272 | 0 |
| K172285 | Ablatherm Fusion | Edap Technomed, Inc. | 2017-10-03 | 67 | 0 |
| K160942 | Sonablate | Sonacare Medical, LLC | 2016-12-21 | 260 | 0 |
| K153023 | Ablatherm Integrated Imaging | Edap Technomed, Inc. | 2015-11-06 | 22 | 0 |
| DEN150011 | Sonablate 450 | Sonacare Medical, LLC | 2015-10-09 | 200 | 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