Disposable Dialyzers SD-ID, SD-2D

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

510(k) Number

K790308 ↗

FDA Product Code

FJI

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Oxygen Saturation Meter Model No. Sm-1

  Not classified

  FDA 510(k) K802847 Active Cleared 16 Dec 1980

• Univox W/Holders, Models Univox-Hl, Hlb, Hlf

  Class II

  FDA 510(k) K894826 Active Cleared 28 Feb 1990

• Q220F Carditomy Reservoir/Modified

  Class II

  FDA 510(k) K790635 Active Cleared 18 Apr 1979

• Flushflo II

  Class II

  FDA 510(k) K812173 Active Cleared 18 Aug 1981

• Bos-2S, Spiraflo Bubble Infant Oxygen.

  Class II

  FDA 510(k) K823273 Active Cleared 5 Jan 1983

• Physiological Pressure Transducer #900

  Class II

  FDA 510(k) K820342 Active Cleared 4 Mar 1982

See all devices from Bentley Laboratories, Inc. →

• Are these dialyzers reusable or single-use, and how should they be handled to maintain sterility?

  These dialyzers (SD-ID and SD-2D) are single-use only and come in sterile packages for clinical use. They must be handled according to the manufacturer’s guidelines to preserve sterility, as reuse is not permitted. Always follow Bentley Laboratories’ instructions to avoid contamination before, during, or after use.

• What types of procedures are these dialyzers designed for, and what do they filter from the blood?

  The SD-ID and SD-2D dialyzers are designed for hemofiltration and hemodialysis, which are renal replacement therapies. They use semipermeable hollow fiber membranes to remove waste products, excess fluids, and electrolytes from the blood through diffusion and convection, effectively mimicking the function of healthy kidneys for patients with acute or chronic kidney failure.

• What regulatory pathway was followed for FDA clearance, and what classification does this device fall under?

  These dialyzers received FDA 510(k) clearance (K790308) under the Traditional 510(k) review pathway, determined to be substantially equivalent to predicate devices. They are classified under FDA regulation 21 CFR 876.5820 as Class II medical devices, indicating a moderate level of regulatory oversight.

• Are there specific storage instructions for these dialyzers, and how should they be stored before use?

  While the provided data does not specify exact storage conditions, as sterile single-use devices, they should be stored in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the manufacturer’s labeling for any additional storage recommendations to ensure functionality and sterility before use.