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FDA 510(k)

twiist system

K-Number: K250930 · 2025-04-02

ApplicantDeka Research & Development Corp.
Decision Date2025-04-02
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

twiist system is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research & Development Corp.. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K250930. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the twiist system?

twiist system is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Deka Research & Development Corp.. The 510(k) number is K250930.

When did twiist system receive FDA 510(k) clearance?

twiist system received FDA 510(k) clearance on 2025-04-02, under 510(k) number K250930.

Who is the listed applicant for twiist system?

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

What is the FDA product code for twiist system?

The FDA product code for twiist system is QFG.

Other records listing Deka Research & Development Corp. as applicant

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Related Devices (Code: QFG)

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.

K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and DevelopmentK253976iLet ACE PumpBeta Bionics, Inc.K253743MiniMed Flex pumpMedtronic Minimed, Inc.K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.K252770iLet ACE PumpBeta Bionics, Inc.

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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