510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NHVClass II

System, Water Purification, General Medical Use

21 CFR 876.5665 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NHV is the FDA product code for System, Water Purification, General Medical Use, a class II device type, regulated under 21 CFR 876.5665. FDA's definition for this code reads: "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...". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NHV
Device name
System, Water Purification, General Medical Use
FDA 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.
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code NHV

By decision year
12 clearances under product code NHV with a decision year between 2002 and 2026, 2016 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code NHV by decision year
YearClearances
20021
20141
20164
20171
20181
20192
20231
20261

Applicants with the most clearances

Product code NHV
Applicants holding the most 510(k) clearances under product code NHV
ApplicantClearances
Nephros Inc3
Microtek Medical LLC2
Pall International, SARL2
Aqua-Tools1
E.A.M Benelux B.V1
Evoqua Water Technologies LLC1
I3 Membrane Corporation1
Prismedical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order