NHV — System, Water Purification, General Medical Use Class II
Classification Details
- Product Code
- NHV
- Device Class
- Class II
- Regulation Number
- 876.5665
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K222727 | i3 membrane | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) | June 2, 2023 |
| K191563 | aqua-tools | FILTRAY 2G Disposable Water Filters | October 25, 2019 |
| K182164 | ecolab | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Eco | March 29, 2019 |
| K173164 | ecolab | Ecolab POU Water Filter | June 29, 2018 |
| K163609 | pall international sarl | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Fau | June 1, 2017 |
| K161467 | nephros | HydraGuard 10 UltraFilter | December 22, 2016 |
| K153784 | evoqua water technologies | NOSOGARD FILTERS | October 21, 2016 |
| K153434 | pall international sarl | Pall-Aquasafe Water Filter | June 10, 2016 |
| K153084 | nephros | Nephros S100 | April 8, 2016 |
| K141731 | nephros | NEPHROS DSU-H, NEPHROS SSU-H | October 24, 2014 |
| K012716 | prismedical | MAINSTREAM WATER PURIFICATION DEVICE | May 7, 2002 |