DeviceClearance

Product code KXM— Gastroenterology, Urology

BAXTER BIOSTAT 1000 UREA MONITOR

Classification name
System Accessories, Extracorporeal
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Total cleared
4
First cleared
Most recent

Market context for product code KXM

FDA has cleared 4 devices under product code KXM between 1983 and 1995, filed by 4 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

Top applicants under product code KXM

Recent clearances under product code KXM

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