HydraGuard 10 UltraFilter
FDA 510(k) K161467 · Nephros, Inc.
510(k) numberK161467
Submission
- Device name
- HydraGuard 10 UltraFilter
- Applicant
- Nephros, Inc.
River Edge, NJ, US - Received
- May 27, 2016
- Decision date
- December 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was HydraGuard 10 UltraFilter cleared by the FDA?
HydraGuard 10 UltraFilter (K161467) received a 510(k) decision of Substantially Equivalent on December 22, 2016, 209 days after the submission was received.
What is the product code of K161467?
The FDA product code is NHV – System, Water Purification, General Medical Use, a Class II (moderate risk) device regulated under 21 CFR 876.5665.