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FDA 510(k)

Sparta Infusion Set for Insulin

K-Number: K243841 · 2025-08-01

ApplicantDeka Research and Development
Decision Date2025-08-01
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sparta Infusion Set for Insulin is a medical device manufactured by Deka Research and Development. It received FDA 510(k) clearance on 2025-08-01 under approval number K243841. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sparta Infusion Set for Insulin?

Sparta Infusion Set for Insulin is a medical device that received FDA 510(k) clearance on 2025-08-01. It is manufactured by Deka Research and Development. The 510(k) number is K243841.

When was Sparta Infusion Set for Insulin approved by the FDA?

Sparta Infusion Set for Insulin received FDA 510(k) clearance on 2025-08-01, under approval number K243841.

What company makes Sparta Infusion Set for Insulin?

Sparta Infusion Set for Insulin is manufactured by Deka Research and Development.

What is the FDA product code for Sparta Infusion Set for Insulin?

The FDA product code for Sparta Infusion Set for Insulin is FPA.

Related Clinical Trials

NCT04542148 Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes ACTIVE_NOT_RECRUITING NCT02812927 Evaluation of Glycemic Variability (GLAIVE) COMPLETED

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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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