K253976
- 510(k) number
- K253976
- Device name
- iLet ACE Pump
- Applicant
- Beta Bionics, Inc. MA · US
- Product code
- QFG — Alternate Controller Enabled Insulin Infusion Pump
- Decision date
- 2026-04-30
- Date received
- 2025-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253976.pdf
Official FDA record: K253976
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.