FDA 510(k)

iLet® ACE Pump

K-Number: K231485 · 2023-06-21

Decision Date2023-06-21

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 2023-06-21 under approval 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. It is manufactured by Beta Bionics, Inc.. The 510(k) number is K231485.

When was iLet® ACE Pump approved by the FDA?

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

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 K223846iLet® ACE Pump K220916iLet® Dosing Decision Software K252770iLet ACE Pump 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

View on FDA Database →

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