K-number	K252770
Device name	iLet ACE Pump
Applicant	Beta Bionics, Inc.
Product code	QFG
Device class	Class II
Decision date	Sep 29, 2025
Decision	Substantially Equivalent
Regulation	880.5730

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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iLet ACE Pump

Everything you need for a 510(k) submission. Nothing you don't.