Blood Administration Sets
Summary
Baxter Healthcare Corporation received 510(k) clearance for Blood Administration Sets, a BRZ device. Cleared on 2022-11-17.
Details
Source
510(k) Clearance
External ID
K220558
Action Date
2022-11-17
Status
Traditional
Category
device
Product Code
BRZ
Product Description
Blood Administration Sets. Product code: BRZ.
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. Baxter Healthcare Corporation has received 24 total clearances in our database.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 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 Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K220558" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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