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FDA 510(k)

Rapid Acoustic Pulse Device

K-Number: K200331 · 2020-03-10

ApplicantSoliton, Inc.
Decision Date2020-03-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Rapid Acoustic Pulse Device is a medical device manufactured by Soliton, Inc.. It received FDA 510(k) clearance on 2020-03-10 under approval number K200331. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid Acoustic Pulse Device?

Rapid Acoustic Pulse Device is a medical device that received FDA 510(k) clearance on 2020-03-10. It is manufactured by Soliton, Inc.. The 510(k) number is K200331.

When was Rapid Acoustic Pulse Device approved by the FDA?

Rapid Acoustic Pulse Device received FDA 510(k) clearance on 2020-03-10, under approval number K200331.

What company makes Rapid Acoustic Pulse Device?

Rapid Acoustic Pulse Device is manufactured by Soliton, Inc..

What is the FDA product code for Rapid Acoustic Pulse Device?

The FDA product code for Rapid Acoustic Pulse Device is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41815749 The history of state preemption and medical device regulation: lessons for artificial intelligence oversight. Health affairs scholar (2026) PMID: 40947420 Software as Medical Devices: requirements and regulatory landscape in the United States. Expert review of medical devices (2025) PMID: 40906998 Recalls of Arthroscopic Equipment After Food and Drug Administration 510(k) Approval: A Twenty-Year Analysis of Causes, Trends, and Time to Recall (2004 to 2024). The Journal of the American Academy of Orthopaedic Surgeons (2026)

Other Devices by Soliton, Inc.

K190542Soliton Acoustic Wave Device K212502Resonic Rapid Acoustic Pulse Device K210964Resonic Rapid Acoustic Pulse Device K201801Rapid Acoustic Pulse Device

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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