DeviceClearance

Product code NHV— Gastroenterology, Urology

Ecolab POU Water Filter

Classification name
System, Water Purification, General Medical Use
Device class
Class 2
Regulation
21 CFR 876.5665
Advisory panel
Gastroenterology, Urology
Total cleared
12
First cleared
Most recent

FDA classification definition

“The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.”

— U.S. Food and Drug Administration, device classification record for product code NHV under 21 CFR 876.5665, via openFDA

Market context for product code NHV

FDA has cleared 12 devices under product code NHV between 2002 and 2026, filed by 8 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 NHV

Recent clearances under product code NHV

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