Data / Medical devices / United States / Spark Biomedical Inc.
Spark Biomedical Inc.: FDA-registered device maker in Richmond, TX, United States, 2 510(k) clearances
Spark Biomedical Inc. is registered with the FDA (registration 3017987352) in Richmond, TX, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 25, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017987352
- Address
- 7535 W Grand Pkwy S, Richmond, TX, United States, 77407
- Owner or operator
- Spark Biomedical Inc (10080441)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 28, 2023
- Registered through
- 2026
- Brand names listed
- Sparrow Ascent
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Percutaneous Nerve Stimulator For Opioid Withdrawal | PZR | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 25, 2025 | K251246 | Sparrow Ascent | PZR | Substantially Equivalent | Spark Biomedical, Inc. | accessdata.fda.gov |
| June 20, 2023 | K230796 | Sparrow Ascent | PZR | Substantially Equivalent | Spark Biomedical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 2, 2025 | 97185 | Class II | Ongoing | Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28 | Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. | accessdata.fda.gov |
Compare with other makers
Updated August 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.