Pulse Biosciences, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Pulse Biosciences, Inc.” (first 2021, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 107 days. Since 2017 the median was 107 days, against 112 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 |
|---|---|---|
| 2021 | 2 | 96 |
| 2022 | 3 | 53 |
| 2023 | 0 | — |
| 2024 | 2 | 123 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pulse Biosciences, Inc. took a median 107 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 7 | 7 |
Review panels
Most recent Pulse Biosciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240782 | CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) | GEI | 2024-08-05 | 137 |
| K233705 | CellFX Percutaneous Electrode System (SYS3000) | GEI | 2024-03-08 | 109 |
| K213674 | CellFX System | GEI | 2022-09-22 | 304 |
| K222075 | CellFX System | GEI | 2022-09-02 | 50 |
| K221671 | CellFX® System | GEI | 2022-08-01 | 53 |
| K211444 | CellFX System | GEI | 2021-08-25 | 107 |
| K203299 | CellFX System | GEI | 2021-02-02 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Pulse Biosciences, 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.
Device clinical trials
An industry sponsor named Pulse Biosciences, Inc. is the lead sponsor of 12 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT07018596: NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System (Recruiting, started 2026-04-06)
- NCT06959121: CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation (Recruiting, started 2025-10-23)
- NCT07287176: Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System (Recruiting, started 2025-08-21)
- NCT06355063: CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation (Recruiting, started 2024-07-31)
- NCT06696170: CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation (Recruiting, started 2024-07-25)
SEC filings
PULSE BIOSCIENCES, INC. (PLSE): EDGAR filings, CIK 1625101. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pulse Time Products, Ltd. (6 510(k)s)
- Pulse Metric, Inc. (5 510(k)s)
- Pulse Biomedical, Inc. (3 510(k)s)
- Pulse Scientific, Inc. (3 510(k)s)
- Pulse Life, Inc. (1 510(k)s)
- Pulse Med, Inc. (1 510(k)s)
- Pulse Medical Instruments (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pulse Biosciences, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Pulse Biosciences, Inc.” (first 2021, 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 Pulse Biosciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pulse Biosciences, Inc. is 107 days. Since 2017: 107 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pulse Biosciences, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 7).
Next steps
- See all 7 Pulse Biosciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Pulse Biosciences, 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.