155 SCE Hemodialyzer

No FDA recalls found in the data synced 6 Oct 2026.

Full name

155 Sce(Tm) Hemodialyzer

510(k) Number

K945631 ↗

FDA Product Code

FJI

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System

  Class II

  FDA 510(k) K964922 Active Cleared 21 May 1997

• Drake Willock System & Altra Touch 1000 Dialysis Delivery System

  Class II

  FDA 510(k) K970446 Active Cleared 2 Jun 1997

• Altra Nova 200 Hemodailyzer

  Class II

  FDA 510(k) K926379 Active Cleared 13 Feb 1995

• Altra Flux(Tm) 170 Hemodialyzer

  Class II

  FDA 510(k) K945542 Active Cleared 23 May 1995

• Altres(R) 140 Hemodialyzer

  Class II

  FDA 510(k) K945596 Active Cleared 8 Mar 1995

• Altratouch 1000 Hemodialysis Delivery System

  Class II

  FDA 510(k) K954987 Active Cleared 8 Aug 1996

See all devices from Althin Medical AB an Affiliate of Baxter Intl →

• What is the 155 SCE Hemodialyzer used for?

  The 155 SCE Hemodialyzer is designed as an artificial kidney to perform hemodialysis. It removes waste products, excess fluids, and electrolytes from the blood of patients with renal failure through diffusion and ultrafiltration. The semipermeable hollow fiber membranes facilitate these processes, mimicking the function of healthy kidneys.

• Is the 155 SCE Hemodialyzer sterile and single-use?

  Yes, the 155 SCE Hemodialyzer is supplied sterile and intended for single-use in clinical settings. This ensures patient safety by preventing cross-contamination and maintaining device integrity for one treatment cycle only.

• What are the key specifications or configurations available for this device?

  The 155 SCE Hemodialyzer is available in standard sizes and configurations as originally submitted to the FDA. These details are documented in the device’s submission records, adhering to FDA’s Substantially Equivalent (SESE) determination for Class II devices. Specific dimensions or variations are not listed in the provided data, but the device is designed for compatibility with standard hemodialysis systems.

• How should the 155 SCE Hemodialyzer be stored?

  While the provided data does not specify storage instructions, sterile medical devices like the 155 SCE Hemodialyzer are typically stored in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Always follow the manufacturer’s instructions or accompanying documentation for optimal storage conditions to preserve sterility and functionality.

• What regulatory pathway does the 155 SCE Hemodialyzer follow?

  The 155 SCE Hemodialyzer was granted a 510(k) clearance (K945631) by the FDA in 1995 under the Traditional clearance type. It is classified under FDA product code FJI and regulated under 21 CFR 876.5820. The device was determined to be Substantially Equivalent (SESE) to a legally marketed predicate, ensuring compliance with FDA standards for Class II medical devices.