Nephros S100
FDA 510(k) K153084 · Nephros, Inc.
510(k) numberK153084
Submission
- Device name
- Nephros S100
- Applicant
- Nephros, Inc.
River Edge, NJ, US - Received
- October 26, 2015
- Decision date
- April 8, 2016
- 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…
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More from Nephros, Inc.
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|---|---|---|
| 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 |
| K141731 | Nephros Dsu-H, Nephros Ssu-HNHV · Traditional | 10/24/2014SE |
| 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 S100 cleared by the FDA?
Nephros S100 (K153084) received a 510(k) decision of Substantially Equivalent on April 8, 2016, 165 days after the submission was received.
What is the product code of K153084?
The FDA product code is NHV – System, Water Purification, General Medical Use, a Class II (moderate risk) device regulated under 21 CFR 876.5665.