2008T BlueStar Hemodialysis Machine
Summary
Fresenius Medical Care Renal Therapies Group, LLC received 510(k) clearance for 2008T BlueStar Hemodialysis Machine, a KDI device. Cleared on 2023-12-06.
Details
Source
510(k) Clearance
External ID
K231125
Action Date
2023-12-06
Status
Traditional
Category
device
Product Code
KDI
Product Description
2008T BlueStar Hemodialysis Machine. Product code: KDI.
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. Fresenius Medical Care Renal Therapies Group, LLC has received 26 total clearances in our database.
Fresenius Medical Care Renal Therapies Group, LLC has 26 FDA actions in our database, including 26 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 Fresenius Medical Care Renal Therapies Group, LLC have FDA actions?
Fresenius Medical Care Renal Therapies Group, LLC has 26 FDA actions in our database, including 0 recalls and 26 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231125" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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