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FDA 510(k)

iLet® ACE Pump

K-Number: K231485 · 2023-06-21

ApplicantBeta Bionics, Inc.
Decision Date2023-06-21
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 2023-06-21 under 510(k) number K231485. 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 2023-06-21. The listed applicant is Beta Bionics, Inc.. The 510(k) number is K231485.

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

iLet® ACE Pump received FDA 510(k) clearance on 2023-06-21, under 510(k) number K231485.

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 PumpK252770iLet ACE PumpK232224iLet® Dosing Decision SoftwareK223846iLet® 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.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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