FDA applicant

Spark Biomedical, Inc.

Dallas, TX3 decisions2021–20251 recall

FDA records 3 decisions for Spark Biomedical, Inc. (Dallas, TX) from 2021 to 2025: 3 510(k) clearances. All are in product code PZR (Percutaneous Nerve Stimulator For Opioid…). Its devices cite 3 predicates, 2 of them its own earlier devices. 1 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, neurology panel, where it files most

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

FDA decisions per year

1in 2025

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2025

2021high 1 (2025) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Spark Biomedical, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spark Biomedical, 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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Other applicant names beginning “Spark”

FDA records each applicant name separately; these may or may not be the same firm.

Spark Instruments & Academics, Inc. 2 Spark Neuro, Inc. 1

Spark Biomedical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Spark”