FDA applicant

HistoSonics, Inc.

Plymouth, MN4 decisions2023–20260 recalls

FDA records 4 decisions for HistoSonics, Inc. (Plymouth, MN) from 2023 to 2026: 3 510(k) clearances and 1 De Novo grant. Most are in product codes QGM (Focused Ultrasound System For Non-Thermal…) and QTZ (Radiological Image Processing Software For…). Its devices cite 3 predicates, 2 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 HistoSonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2023high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — HistoSonics, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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HistoSonics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?