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FDA 510(k)

DEKA Loop

K-Number: K234055 · 2024-03-13

ApplicantDeka Research and Development
Decision Date2024-03-13
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DEKA Loop 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 2024-03-13 under 510(k) number K234055. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEKA Loop?

DEKA Loop is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Deka Research and Development. The 510(k) number is K234055.

When did DEKA Loop receive FDA 510(k) clearance?

DEKA Loop received FDA 510(k) clearance on 2024-03-13, under 510(k) number K234055.

Who is the listed applicant for DEKA Loop?

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 DEKA Loop?

The FDA product code for DEKA Loop is QJI.

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Related Devices (Code: QJI)

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.

K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMedK261461Omnipod 6 algorithmInsulet CorporationK260429Control-IQ+ technologyTandem Diabetes Care, Inc.K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MinimedK253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.K251152DBLG2Diabeloop

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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