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FDA 510(k)

iLet ACE Pump

K-Number: K252770 · 2025-09-29

ApplicantBeta Bionics, Inc.
Decision Date2025-09-29
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

iLet ACE Pump is the device name listed in this FDA 510(k) record. The listed applicant is Beta Bionics, Inc.. It received FDA 510(k) clearance on 2025-09-29 under 510(k) number K252770. 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 iLet ACE Pump?

iLet ACE Pump is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Beta Bionics, Inc.. The 510(k) number is K252770.

When did iLet ACE Pump receive FDA 510(k) clearance?

iLet ACE Pump received FDA 510(k) clearance on 2025-09-29, under 510(k) number K252770.

Who is the listed applicant for iLet ACE Pump?

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

What is the FDA product code for iLet ACE Pump?

The FDA product code for iLet ACE Pump is QFG.

Other records listing Beta Bionics, 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.

K253976iLet ACE PumpK232224iLet® Dosing Decision SoftwareK231485iLet® ACE PumpK223846iLet® ACE PumpK220916iLet® Dosing Decision Software

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.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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