Home / 510(k) Clearances / K110578

510(k) K110578

MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM by Mar Cor Purification, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2011
Date Received
March 1, 2011
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 Mar Cor Purification, Inc.

  • K200670 — EON Portable RO Water Purification System (April 16, 2020)
  • K192398 — Millenium HX (October 3, 2019)
  • K133149 — BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM (April 30, 2014)

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)