pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
Summary
Fresenius Medical Care Renal Therapies Group, LLC received 510(k) clearance for pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504, a KPO device. Cleared on 2023-12-01.
Details
Source
510(k) Clearance
External ID
K233159
Action Date
2023-12-01
Status
Traditional
Category
device
Product Code
KPO
Product Description
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504. Product code: KPO.
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 "K233159" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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