Home / 510(k) Clearances / K041163

510(k) K041163

ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES by Isopure, Corp. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2004
Date Received
May 3, 2004
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 Isopure, Corp.

  • K191093 — Isopure Dry Acid Dissolution System (January 22, 2020)
  • K120005 — ACDS (March 29, 2012)
  • K112427 — BICARB MIXING AND DISTRIBUTION SYSTEM (January 26, 2012)
  • K993200 — MD 420/440/460/470/480/490 (January 24, 2000)

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)