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510(k) K161304

EndoPur Filter by Nephros, Inc. — Product Code FIP

K161304 is an FDA 510(k) premarket notification submitted by Nephros, Inc. for the device "EndoPur Filter". The FDA issued a decision of Substantially Equivalent on March 2, 2017. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Nephros, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2017
Date Received
May 10, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type

Other clearances by Nephros, Inc.

  • K210575 — HDF Assist Mudule, HDF Infusion Set and Substitution Filter (May 13, 2022)
  • K161467 — HydraGuard 10 UltraFilter (December 22, 2016)
  • K153084 — Nephros S100 (April 8, 2016)
  • K141731 — NEPHROS DSU-H, NEPHROS SSU-H (October 24, 2014)
  • K112314 — NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER (April 27, 2012)
  • K110285 — NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER (July 14, 2011)
  • K090885 — NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER (June 29, 2009)
  • K050603 — OLPUR DIALYZER, MODEL HD 190 (June 9, 2005)

Other clearances for product code FIP

  • K250471 — AquaC UNO H (November 14, 2025)
  • K251851 — DIASAFEplusUS (F00013010) (October 9, 2025)
  • K252181 — AquaA (September 9, 2025)
  • K250514 — UPT Series Medical RO Water Treatment System (March 17, 2025)
  • K232953 — AquaBplus; AquaB LITE (June 13, 2024)
  • K223479 — AQUAbase nX (August 16, 2023)
  • K231410 — RenaPure Endotoxin Retentive Filter (July 19, 2023)
  • K223656 — AmeriWater MediQA Reverse Osmosis System (MSP3HF) (February 13, 2023)
  • K213507 — AquaA (July 27, 2022)
  • K211035 — U9000 Plus Ultrafilter (October 19, 2021)

FDA data resources