FDA applicant

Pulse Biosciences, Inc.

Hayward, CA7 decisions2021–20240 recalls

FDA records 7 decisions for Pulse Biosciences, Inc. (Hayward, CA) from 2021 to 2024: 7 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 107 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Pulse Biosciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2021high 3 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Pulse Biosciences, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pulse Biosciences, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Pulse”

FDA records each applicant name separately; these may or may not be the same firm.

Pulse Time Products, Ltd. 6 Pulse Metric, Inc. 5 Pulse Biomedical, Inc. 3 Pulse Scientific, Inc. 3 Pulse Medical Instruments 1 Pulse Life, Inc. 1 Pulse Med, Inc. 1

Pulse Biosciences, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Pulse”