embecta Insulin Delivery System— 510(k) K234027

Name: FDA 510(k) clearance K234027
Creator: U.S. Food and Drug Administration
Published: 2024-08-30

Substantially Equivalent

Embecta Medical I, LLC

FDA 510(k) clearance K234027 for embecta Insulin Delivery System, Substantially Equivalent on 2024-08-30. Applicant: Embecta Medical I, LLC. Device class: 2.

Clearance details

Applicant: Embecta Medical I, LLC
Product code: Code QFG
Device class: Class 2
Regulation: 21 CFR 880.5730
Advisory panel: Clinical Chemistry
Date received: 2023-12-20
Decision date: 2024-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QFG

view all

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

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.