Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pulse Biosciences, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
304 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240782 | CellFX Percutaneous Electrode System (SYS3000); CellFX Percu | Pulse Biosciences, Inc. | 2024-08-05 | 137 | 0 |
| K233705 | CellFX Percutaneous Electrode System (SYS3000) | Pulse Biosciences, Inc. | 2024-03-08 | 109 | 0 |
| K213674 | CellFX System | Pulse Biosciences, Inc. | 2022-09-22 | 304 | 0 |
| K222075 | CellFX System | Pulse Biosciences, Inc. | 2022-09-02 | 50 | 0 |
| K221671 | CellFX® System | Pulse Biosciences, Inc. | 2022-08-01 | 53 | 0 |
| K211444 | CellFX System | Pulse Biosciences, Inc. | 2021-08-25 | 107 | 0 |
| K203299 | CellFX System | Pulse Biosciences, Inc. | 2021-02-02 | 85 | 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