FDA applicant

Power Products, Inc.-Splintek

Lenexa, KS3 decisions2003–20100 recalls

FDA records 3 decisions for Power Products, Inc.-Splintek (Lenexa, KS) from 2003 to 2010: 3 510(k) clearances. Most are in product codes MQC (Mouthguard, Prescription) and OBR (Mouthguard, Over-The-Counter). Its devices cite 3 predicates, 1 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

How often FDA has decided Power Products, Inc.-Splintek’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Power Products, Inc.-Splintek by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Power Products, Inc.-Splintek’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 “Power”

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

Power Medical Interventions, Inc. 22 Power Plus Mobility 1 Power Analytics Corp. 1 Power Medical Devices, LLC 1

Power Products, Inc.-Splintek

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?

Other applicant names beginning “Power”