Cobe Hemoflo Blood Tubing Sets

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K801211 ↗

FDA Product Code

FJK

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Flowmeter, Optiflo Gas

  Class II

  FDA 510(k) K790546 Active Cleared 11 May 1979

• Cobe Ppd 1.9

  Class II

  FDA 510(k) K812336 Active Cleared 31 Aug 1981

• Cobe Spectra Blood Component Separator Therapeutic

  Unclassified

  FDA 510(k) K900105 Active Cleared 22 Mar 1991

• Cobe Emergency Power Source 43610-000

  Class II

  FDA 510(k) K842138 Active Cleared 3 Aug 1984

• Centry 2 Ultrafiltration Control Kit, #018762-002

  Class II

  FDA 510(k) K881062 Active Cleared 21 Apr 1988

• Cobe Rx Meter

  Class II

  FDA 510(k) K830629 Active Cleared 6 Apr 1983

See all devices from Cobe Laboratories, Inc. →

• What clinical procedures are these blood tubing sets primarily intended for, and why are they designed this way?

  The Cobe Hemoflo Blood Tubing Sets are primarily designed for hemodialysis and related extracorporeal blood circuits, including procedures in urology and gastroenterology. They incorporate tubing with and without anti-regurgitation valves to ensure controlled blood flow during therapeutic procedures, which is critical for maintaining patient safety and system integrity during blood processing.

• Are these tubing sets reusable, and if not, what does that mean for clinical workflows?

  No, these tubing sets are sterile, single-use only, meaning each set is intended for one-time use in a single patient procedure. This design minimizes infection risks and ensures consistent performance, but it requires clinicians to manage inventory and waste disposal accordingly, as they cannot be reused or reprocessed.

• How should these tubing sets be stored, and what precautions should be taken before use?

  Since they are sterile and single-use, these sets should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediately before use to preserve sterility. Always check the expiration date and inspect for damage before opening.

• What does the FDA’s 510(k) clearance (K801211) from 1980 indicate about the device’s regulatory path?

  The FDA’s 510(k) clearance (K801211) confirms that the Cobe Hemoflo Blood Tubing Sets were determined to be substantially equivalent to a legally marketed device at the time of submission. This traditional review process (without third-party involvement) means the device met FDA requirements for safety and effectiveness as of 1980, though ongoing compliance with current regulations remains the responsibility of the manufacturer and user.

• Do these sets come in multiple sizes or configurations, and how might that affect selection for a procedure?

  While the exact sizes or model variations aren’t detailed in the data, the product codes (e.g., FJK) and the mention of tubing with and without anti-regurgitation valves suggest there may be multiple configurations. Clinicians should select the appropriate set based on the specific extracorporeal blood circuit requirements (e.g., flow rate, valve needs) and compatibility with their dialysis machine or procedural setup.