SmartAdjust(TM) technology— 510(k) K232741

Name: FDA 510(k) clearance K232741
Creator: U.S. Food and Drug Administration
Published: 2024-05-29

Substantially Equivalent

Insulet Corporation

FDA 510(k) clearance K232741 for SmartAdjust(TM) technology, Substantially Equivalent on 2024-05-29. Applicant: Insulet Corporation. Device class: 2.

Clearance details

Applicant: Insulet Corporation
Product code: Code QJI
Device class: Class 2
Regulation: 21 CFR 862.1356
Advisory panel: Clinical Chemistry
Date received: 2023-09-07
Decision date: 2024-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code QJI

product code QJI

Other: 3
Total: 3

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.