510(k) K252770

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

September 29, 2025

Date Received

September 2, 2025

Clearance Type

Special

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Alternate Controller Enabled Insulin Infusion Pump

Device Class

Class II

Regulation Number

880.5730

Review Panel

CH

Submission Type

An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.