Capillary Flow Dialyzers Models ST-12 & ST-15

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

510(k) Number

K871471 ↗

FDA Product Code

FJI

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K780970 Active Cleared 27 Jul 1978

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See all devices from Travenol Laboratories, S.A. →

• Are these dialyzers reusable or intended for single-use only, and why does that matter in a clinical setting?

  These Capillary Flow Dialyzers (Models ST-12 & ST-15) are explicitly designed for single-use only in clinical settings like hospitals and dialysis centers. This is critical because single-use devices eliminate the risk of cross-contamination between patients, which is a major concern in blood purification therapies. Since they are supplied sterile and packaged individually, there’s no need for additional sterilization or reprocessing, ensuring patient safety and compliance with FDA guidelines for extracorporeal blood treatments.

• What sizes or models are available, and how do I determine which one to use for a patient?

  The available models are ST-12 and ST-15, which refer to their specific design parameters (likely surface area or fiber configuration). While the exact clinical differentiation isn’t detailed here, the choice typically depends on factors like patient size, blood flow requirements, and the intended filtration rate for hemofiltration. Consulting the manufacturer’s instructions or a nephrology specialist is recommended to match the model to the patient’s needs, as these dialyzers are used in gastroenterology and urology-related extracorporeal therapies.

• How should these dialyzers be stored, and what precautions should be taken to maintain their sterility?

  The dialyzers are supplied sterile and individually packaged, so storage should follow the manufacturer’s guidelines to preserve sterility. They should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Since they’re single-use, avoid opening the packaging until immediately before use, and handle with sterile technique to prevent contamination. Proper storage ensures the semipermeable hollow fiber membranes remain intact for safe, effective hemofiltration.

• What regulatory pathway was followed for FDA clearance, and what does that mean for clinicians using these devices?

  These dialyzers received FDA 510(k) clearance (K871471) under the traditional review pathway, with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined they meet the same performance standards as an existing approved device, ensuring safety and effectiveness for hemofiltration and related extracorporeal blood purification therapies. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should still follow facility protocols and manufacturer instructions for proper use in gastroenterology and urology applications.