K252770
- 510(k) number
- K252770
- Device name
- iLet ACE Pump
- Applicant
- Beta Bionics, Inc. MA · US
- Product code
- QFG — Alternate Controller Enabled Insulin Infusion Pump
- Decision date
- 2025-09-29
- Date received
- 2025-09-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252770.pdf
Official FDA record: K252770
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.