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FDA 510(k)

Tandem Mobi insulin pump with interoperable technology

K-Number: K253074 · 2025-11-06

ApplicantTandem Diabetes Care, Inc.
Decision Date2025-11-06
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Tandem Mobi insulin pump with interoperable technology is the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K253074. 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 Tandem Mobi insulin pump with interoperable technology?

Tandem Mobi insulin pump with interoperable technology is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K253074.

When did Tandem Mobi insulin pump with interoperable technology receive FDA 510(k) clearance?

Tandem Mobi insulin pump with interoperable technology received FDA 510(k) clearance on 2025-11-06, under 510(k) number K253074.

Who is the listed applicant for Tandem Mobi insulin pump with interoperable technology?

The FDA 510(k) record lists Tandem Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tandem Mobi insulin pump with interoperable technology?

The FDA product code for Tandem Mobi insulin pump with interoperable technology is QFG.

Related Clinical Trials

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.

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Other records listing Tandem Diabetes Care, Inc. as applicant

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.

K260429Control-IQ+ technologyK250792t:slim X2 insulin pump with interoperable technologyK251854SteadiSet infusion setK250798Control-IQ+ technologyK243823Control-IQ+ technologyK241078Tandem Mobi Insulin Pump with interoperable technology

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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.K252770iLet ACE PumpBeta Bionics, Inc.K250792t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, 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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