DeviceClearance

Product code FIP— Gastroenterology, Urology

WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS

Classification name
Subsystem, Water Purification
Device class
Class 2
Regulation
21 CFR 876.5665
Advisory panel
Gastroenterology, Urology
Total cleared
117
First cleared
Most recent

Market context for product code FIP

FDA has cleared 117 devices under product code FIP between 1977 and 2025, filed by 85 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 FIP

Adverse events under product code FIP

product code FIP
Malfunction
490
Total
490

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 FIP

1–100 of 117

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