FDA.report

510(k) K251779

Device
Omnipod 5 algorithm
Applicant
Insulet Corporation
510(k) number
K251779
Product code
QJI
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-03
Date received
2025-06-10
Regulation
862.1356
Classification name
Interoperable Automated Glycemic Controller
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Alexander Hamad
Address
100 Nagog Park Acton MA US 01720 01720

FDA Registration Numbers

Source Documents

510(k) summary PDF

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