iLet® ACE Pump— 510(k) K231485

Name: FDA 510(k) clearance K231485
Creator: U.S. Food and Drug Administration
Published: 2023-06-21

Substantially Equivalent

Beta Bionics, Inc.

FDA 510(k) clearance K231485 for iLet® ACE Pump, Substantially Equivalent on 2023-06-21. Applicant: Beta Bionics, Inc.. Device class: 2.

Clearance details

Applicant: Beta Bionics, Inc.
Product code: Code QFG
Device class: Class 2
Regulation: 21 CFR 880.5730
Advisory panel: Clinical Chemistry
Date received: 2023-05-23
Decision date: 2023-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Concord, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QFG

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K260001 — Mint ACE Pump2026-09-11
K261672 — twiist Automated Insulin Delivery (AID) System2026-06-17
K253976 — iLet ACE Pump2026-04-30
K253743 — MiniMed Flex pump2026-03-12
K253470 — MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)2026-01-15

More clearances from Beta Bionics, Inc.

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K262763 — iLet Dosing Decision Software2026-09-11
K252770 — iLet ACE Pump2025-09-29
K232224 — iLet® Dosing Decision Software2023-09-22
K220916 — iLet® Dosing Decision Software2023-05-19
K223846 — iLet® ACE Pump2023-05-19

Adverse events under product code QFG

product code QFG

Death: 228
Injury: 118,915
Malfunction: 1,001,752
Other: 7
Total: 1,120,902

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.