Disposable Blood Line Connectors

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

510(k) Number

K821495 ↗

FDA Product Code

KOC

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. →

• What are Disposable Blood Line Connectors used for?

  Disposable Blood Line Connectors are used to connect tubing within extracorporeal blood pathways during hemodialysis, serving as accessories for blood circuits in renal replacement therapy to ensure secure and sterile connections between circuit components.

• Are Disposable Blood Line Connectors sterile and single-use?

  Yes, these connectors are supplied sterile and are intended for single-use only, as stated in the device description, to prevent cross-contamination and ensure patient safety during hemodialysis procedures.

• What regulatory pathway applies to Disposable Blood Line Connectors?

  Disposable Blood Line Connectors are regulated as Class II medical devices under FDA 510(k) clearance K821495, with product code KOC and regulation number 876.5820, indicating they were cleared through the traditional 510(k) process as substantially equivalent to a predicate device.