Home / 510(k) Clearances / K223479

510(k) K223479

AQUAbase nX by B.Braun Medical, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2023
Date Received
November 18, 2022
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 B.Braun Medical, Inc.

  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter (July 31, 2024)
  • K241845 — Introcan Safety® 2 IV Catheter (July 26, 2024)
  • K241385 — Omnifix Syringe NRFit (July 13, 2024)
  • K231242 — Perifix FX Catheter; Contiplex FX Catheter (September 15, 2023)
  • K220756 — Introcan Safety 2 IV Catheter (June 23, 2022)
  • K220626 — Introcan Safety IV Catheter (May 14, 2022)
  • K213778 — IV Administration Set (March 3, 2022)
  • K213664 — B. Braun Introcan Safety 2 IV Catheter (February 11, 2022)
  • K212842 — Microvolume Luer Access Device (January 18, 2022)

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)
  • 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)
  • K200670 — EON Portable RO Water Purification System (April 16, 2020)