Identifiers
- 510(k) Number
- K231485 FDA 510(k)
- FDA Product Code
- QFG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5730 FDA 510(k)
- Regulation Number
- 880.5730 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The iLet ACE Pump is an alternate controller enabled insulin infusion pump designed for diabetes management. It functions as an insulin delivery system that automates dosing decisions based on continuous glucose monitoring data.
The device is manufactured by Beta Bionics, Inc. and is a Class II medical device with FDA 510(k) clearance. It is supplied as a reusable pump system and complies with FDA Quality System Regulation 21 CFR 820 and ISO 13485 standards.
Frequently asked questions
What is the iLet ACE Pump used for?
The iLet ACE Pump is an alternate controller enabled insulin infusion pump designed for diabetes management. It functions as an insulin delivery system that automates dosing decisions based on continuous glucose monitoring data.
Is the iLet ACE Pump reusable or single-use?
The iLet ACE Pump is supplied as a reusable pump system. It is designed for multiple uses and complies with FDA Quality System Regulation 21 CFR 820 and ISO 13485 standards.
What is the regulatory status of the iLet ACE Pump?
The iLet ACE Pump is a Class II medical device with FDA 510(k) clearance. It has been determined to be substantially equivalent to predicate devices in the alternate controller enabled insulin infusion pump category.
Who manufactures the iLet ACE Pump?
The iLet ACE Pump is manufactured by Beta Bionics, Inc., located in Concord, MA. The company is responsible for the design, production, and quality control of the device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Beta Bionics - iLet Bionic Pancreas - the insulin pump that ..., PDF September 29, 2025 Beta Bionics, Inc. Liz Cooper Principal Regulatory ..., How the iLet ACE Closed-Loop Insulin Pump is So User-Friendly
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231485 | Class II | Active |
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Manufacturer
- Manufacturer
- Beta Bionics, Inc.
Sources (1)
- FDA 510(k) K231485 24 fields · synced Sep 27, 2026