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FDA 510(k)

iLet ACE Pump

K-Number: K253976 · 2026-04-30

ApplicantBeta Bionics, Inc.
Decision Date2026-04-30
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

iLet ACE Pump is a medical device manufactured by Beta Bionics, Inc.. It received FDA 510(k) clearance on 2026-04-30 under approval number K253976. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iLet ACE Pump?

iLet ACE Pump is a medical device that received FDA 510(k) clearance on 2026-04-30. It is manufactured by Beta Bionics, Inc.. The 510(k) number is K253976.

When was iLet ACE Pump approved by the FDA?

iLet ACE Pump received FDA 510(k) clearance on 2026-04-30, under approval number K253976.

What company makes iLet ACE Pump?

iLet ACE Pump is manufactured by Beta Bionics, Inc..

What is the FDA product code for iLet ACE Pump?

The FDA product code for iLet ACE Pump is QFG.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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