Medical Device Manufacturer · US , Dallas , TX

Spark Biomedical, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2021

Total

Cleared

Denied

Spark Biomedical, Inc. has 3 FDA 510(k) cleared medical devices. Based in Dallas, US.

Latest FDA clearance: Aug 2025. Active since 2021. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Spark Biomedical, Inc. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by RQM+ and Acknowledge Regulatory Strategies, LLC. 1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Spark Biomedical, Inc.

3 devices

1-3 of 3

Cleared CT Jan 02, 2021

Sparrow Therapy System

K201873 · PZR

Neurology · 179d

Regulatory Intelligence

Linked clinical trials FDA-regulated device evidence

Regulatory consultants 510(k) submission support ecosystem

RQM+

Acknowledge Regulatory Strategies, LLC

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Clinical validation data available

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026

Spark Biomedical, Inc. - FDA 510(k) Cleared Devices

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