Home / 510(k) Clearances / K110285

510(k) K110285

NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER by Nephros, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2011
Date Received
January 31, 2011
Clearance Type
Special
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)
  • K161304 — EndoPur Filter (March 2, 2017)
  • 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)
  • 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)