Nephros Dsu-H, Nephros Ssu-H
FDA 510(k) K141731 · Nephros, Inc.
510(k) numberK141731
Submission
- Device name
- Nephros Dsu-H, Nephros Ssu-H
- Applicant
- Nephros, Inc.
River Edge, NJ, US - Received
- June 27, 2014
- Decision date
- October 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NHV – System, Water Purification, General Medical Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5665
- Specialty
- Gastroenterology, Urology
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…
Other 510(k)s with product code NHV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261470 | PurGuard360(QF10)NHV · Traditional | E.A.M Benelux B.V | 09/09/2026SE |
| K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)NHV · Traditional | I3 Membrane GmbH | 06/02/2023SE |
| K191563 | FILTRAY 2G Disposable Water FiltersNHV · Traditional | Aqua-Tools | 10/25/2019SE |
| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU…NHV · Special | Ecolab, Inc. | 03/29/2019SE |
| K173164 | Ecolab POU Water FilterNHV · Traditional | Ecolab, Inc. | 06/29/2018SE |
| K163609 | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)NHV · Traditional | Pall International Sarl | 06/01/2017SE |
| K161467 | HydraGuard 10 UltraFilterNHV · Special | Nephros, Inc. | 12/22/2016SE |
| K153784 | Nosogard FiltersNHV · Traditional | Evoqua Water Technologies, LLC | 10/21/2016SE |
| K153434 | Pall-Aquasafe Water FilterNHV · Traditional | Pall International Sarl | 06/10/2016SE |
| K153084 | Nephros S100NHV · Traditional | Nephros, Inc. | 04/08/2016SE |
More from Nephros, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution FilterKDI · Traditional | 05/13/2022SE |
| K161304 | EndoPur FilterFIP · Traditional | 03/02/2017SE |
| K161467 | HydraGuard 10 UltraFilterNHV · Special | 12/22/2016SE |
| K153084 | Nephros S100NHV · Traditional | 04/08/2016SE |
| K112314 | Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterKDI · Traditional | 04/27/2012SE |
| K110285 | Nephros Dsu Filter, Nephros Msu Filter, Nephros Ssu FilterFIP · Special | 07/14/2011SE |
| K090885 | Nephros, Inc., Dsu Dual Stage UltrafilterFIP · Traditional | 06/29/2009SE |
| K050603 | Olpur Dialyzer, Model HD 190KDI · Traditional | 06/09/2005SE |
Questions and answers
When was Nephros Dsu-H, Nephros Ssu-H cleared by the FDA?
Nephros Dsu-H, Nephros Ssu-H (K141731) received a 510(k) decision of Substantially Equivalent on October 24, 2014, 119 days after the submission was received.
What is the product code of K141731?
The FDA product code is NHV – System, Water Purification, General Medical Use, a Class II (moderate risk) device regulated under 21 CFR 876.5665.