FDA 510(k)

iLet ACE Pump

K-Number: K252770 · 2025-09-29

Decision Date2025-09-29

Product CodeQFG

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

iLet ACE Pump is a medical device manufactured by Beta Bionics, Inc.. It received FDA 510(k) clearance on 2025-09-29 under approval 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. It is manufactured by Beta Bionics, Inc.. The 510(k) number is K252770.

When was iLet ACE Pump approved by the FDA?

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

What company makes iLet ACE Pump?

iLet ACE Pump is manufactured by Beta Bionics, Inc..

What is the FDA product code for iLet ACE Pump?

The FDA product code for iLet ACE Pump is QFG.

Other Devices by Beta Bionics, Inc.

K232224iLet® Dosing Decision Software K231485iLet® ACE Pump K223846iLet® ACE Pump K220916iLet® Dosing Decision Software K253976iLet ACE Pump

Related Devices (Code: QFG)

K191679Omnipod DASH Insulin Management System with interoperable technologyInsulet Corporation DEN180058t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. K203768Omnipod 5 ACE Pump (Pod)Insulet Corporation K230545Inessa SystemTriple Jump Israel , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.