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FDA 510(k)

iiSure Infusion Set

K-Number: K261530 · 2026-06-03

ApplicantDeka Research and Development
Decision Date2026-06-03
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

iiSure Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K261530. 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 iiSure Infusion Set?

iiSure Infusion Set is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Deka Research and Development. The 510(k) number is K261530.

When did iiSure Infusion Set receive FDA 510(k) clearance?

iiSure Infusion Set received FDA 510(k) clearance on 2026-06-03, under 510(k) number K261530.

Who is the listed applicant for iiSure Infusion Set?

The FDA 510(k) record lists Deka Research and Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iiSure Infusion Set?

The FDA product code for iiSure Infusion Set is FPA.

Related Clinical Trials

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NCT06853990Innovative Automated Insulin Delivery System for Type 2 DiabetesCOMPLETED

Other records listing Deka Research and Development as applicant

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Related Devices (Code: FPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.K251854SteadiSet infusion setTandem Diabetes Care

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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