Omnipod 5 ACE Pump
Summary
Insulet Corporation received 510(k) clearance for Omnipod 5 ACE Pump, a QFG device. Cleared on 2023-10-18.
Details
Source
510(k) Clearance
External ID
K231826
Action Date
2023-10-18
Status
Traditional
Category
device
Product Code
QFG
Product Description
Omnipod 5 ACE Pump. Product code: QFG.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Insulet Corporation has received 10 total clearances in our database.
Insulet Corporation has 17 FDA actions in our database, including 7 recalls and 10 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Insulet Corporation have FDA actions?
Insulet Corporation has 17 FDA actions in our database, including 7 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231826" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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