System, Water Purification, General Medical Use
The Water Purification System for General Medical Use is a portable water treatment device featuring components and technology similar to hemodialysis water treatment systems, but intended for general-purpose water purification in medical settings rather than hemodialysis. Its intended uses include washing surgeons' hands, cleaning surgical instruments, and wound cleansing. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NHV and regulation 21 CFR 876.5665 in the Gastroenterology and Urology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- NHV
- Device Class
- FDA class 2
- Regulation Number
- 876.5665
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) | Jun 02, 2023 | Substantially Equivalent | I3 Membrane GmbH |
| K191563 | FILTRAY 2G Disposable Water Filters | Oct 25, 2019 | Substantially Equivalent | Aqua-Tools |
| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand | Mar 29, 2019 | Substantially Equivalent | Ecolab, Inc. |
| K173164 | Ecolab POU Water Filter | Jun 29, 2018 | Substantially Equivalent | Ecolab, Inc. |
| K163609 | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) | Jun 01, 2017 | Substantially Equivalent | Pall International Sarl |
| K161467 | HydraGuard 10 UltraFilter | Dec 22, 2016 | Substantially Equivalent | Nephros, Inc. |
| K153784 | NOSOGARD FILTERS | Oct 21, 2016 | Substantially Equivalent | Evoqua Water Technologies, LLC |
| K153434 | Pall-Aquasafe Water Filter | Jun 10, 2016 | Substantially Equivalent | Pall International Sarl |
| K153084 | Nephros S100 | Apr 08, 2016 | Substantially Equivalent | Nephros, Inc. |
| K141731 | NEPHROS DSU-H, NEPHROS SSU-H | Oct 24, 2014 | Substantially Equivalent | Nephros, Inc. |
| K012716 | MAINSTREAM WATER PURIFICATION DEVICE | May 07, 2002 | Substantially Equivalent | Prismedical Corp. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.