DeviceClearance

Omnipod 5 ACE Pump— 510(k) K231826

Substantially Equivalent

Insulet Corporation

FDA 510(k) clearance K231826 for Omnipod 5 ACE Pump, Substantially Equivalent on 2023-10-18. Applicant: Insulet Corporation. Device class: 2.

Clearance details

Applicant
Insulet Corporation
Product code
Code QFG
Device class
Class 2
Regulation
21 CFR 880.5730
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Acton, MA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Insulet Corporation

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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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K231826

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K231826.

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