Beeline System

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

510(k) Number

K032642 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Mckinley Outbound-2 System

  Class II

  FDA 510(k) K971844 Active Cleared 23 Jan 1998

• Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits

  Class II

  FDA 510(k) K033039 Active Cleared 7 Oct 2003

• Beeline Motiv, Propolis, PCA

  Class II

  FDA 510(k) K042228 Active Cleared 8 Nov 2004

• Walkmed 300, Walkmed 350, Walkmed Ic, Walkmed Pca, Walkmed Plus

  Class II

  FDA 510(k) K991275 Active Cleared 1 Jul 1999

• Outbound Disposable Syringe Infuser Outbound 2 Disposable Pump

  Class II

  FDA 510(k) K982256 Active Cleared 30 Sep 1998

• McKinley SP Disposable Infusion Pump

  Class II

  FDA 510(k) K990461 Active Cleared 30 Jun 1999

• What types of fluids or medications can the Beeline System deliver, and how does it differ from earlier models?

  The Beeline System is designed for controlled delivery of intravenous, intra-arterial, enteral, subcutaneous, percutaneous, and epidural fluids or medications, supporting both continuous and intermittent infusion applications like antibiotic delivery, chemotherapy, and pain management. Unlike prior models, it offers extended flow rate ranges and larger reservoir options, providing greater flexibility for various clinical needs.

• Is the Beeline System reusable, and what processing requirements does it have?

  Yes, the Beeline System is supplied as a reusable device and is not sterile upon packaging. It must be processed according to facility protocols before use, as it is not intended for single-use or sterile out-of-the-box applications.

• What types of clinical settings is the Beeline System intended for, and how does its regulatory clearance support that use?

  The Beeline System is authorized for use in general hospital settings, as indicated by its FDA 510(k) clearance under the classification for infusion pumps (device class 2). The clearance was granted as substantially equivalent to a prior submission, adhering to regulatory requirements under 21 CFR 880.5725, which aligns with its intended use in standard hospital environments.

• Does the Beeline System have any special considerations for use in imaging environments like MRI?

  No, the Beeline System is explicitly not classified as MRI-safe. Clinicians should ensure it is not used in MRI environments unless proper shielding or alternative imaging modalities are employed to avoid interference or safety risks.

• How many different models or configurations of the Beeline System are available, and what distinguishes them?

  The Beeline System includes multiple configurations, as evidenced by its extensive list of FEI numbers (e.g., 3009754410, 3008717264, etc.), which likely correspond to different reservoir sizes, flow rates, or procedural kits. While exact specifications aren’t detailed here, the system’s design emphasizes extended flow rate ranges and larger reservoir options compared to predecessors, catering to varied clinical demands.