DeviceClearance

Product code FKX— Gastroenterology, Urology

Fresenius Liberty Select Cycler

Classification name
System, Peritoneal, Automatic Delivery
Device class
Class 2
Regulation
21 CFR 876.5630
Advisory panel
Gastroenterology, Urology
Total cleared
83
First cleared
Most recent

Market context for product code FKX

FDA has cleared 83 devices under product code FKX between 1977 and 2025, filed by 35 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code FKX

Adverse events under product code FKX

product code FKX
Death
501
Injury
6,720
Malfunction
18,508
Other
1
Total
25,730

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code FKX

Data sourced from openFDA. This site is unofficial and independent of the FDA.