510(k) Report

FDA applicant

Sonomotion, Inc.

San Mateo, CA4 decisions2024–20260 recalls

FDA records 4 decisions for Sonomotion, Inc. (San Mateo, CA) from 2024 to 2026: 3 510(k) clearances and 1 De Novo grant. Most are in product codes QNA (Ultrasonic Urinary Stone Propulsion Device) and LNS (Lithotriptor, Extracorporeal Shock-Wave…). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2024

2024: 12026 (partial year): 3
2024high 3 (2026) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Sonomotion, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • QNAUltrasonic Urinary Stone Propulsion Device2decisions
  • LNSLithotriptor, Extracorporeal Shock-Wave, Urological2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN230082Stone Clear (SC-LP9-01)Sonomotion, Inc. · 20241cites it
  • K252913Break WaveSonomotion, Inc. · 20261cites it

What has FDA decided for it lately?

  • K262200Stone Clear (BWSC-LP9-02)Sonomotion, Inc. · 2026
  • K261086Break WaveSonomotion, Inc. · 2026
  • K252913Break WaveSonomotion, Inc. · 2026
  • DEN230082Stone Clear (SC-LP9-01)Sonomotion, Inc. · 2024

All 4 as Sonomotion, Inc. →