Correct Flo Intravascular Administration Set

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

510(k) Number

K850506 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Pressure Infusor for I.V. Bags/Autoinflation

  Class II

  FDA 510(k) K890268 Active Cleared 5 May 1989

• Infusable

  Class I

  FDA 510(k) K911216 Active Cleared 22 Jul 1991

• Biomedical Dynamics Disposable Pressure Infusor

  Class I

  FDA 510(k) K861977 Active Cleared 15 Jul 1986

• Pressure Infuser

  Class I

  FDA 510(k) K913751 Active Cleared 9 Jan 1992

• Blood Pressure Cuff

  Class II

  FDA 510(k) K881799 Active Cleared 14 Oct 1988

• Aneroid Blood Pressure Gauge

  Class I

  FDA 510(k) K904376 Active Cleared 20 Dec 1990

See all devices from Biomedical Dynamics, Inc. →

• What is the Correct Flo Intravascular Administration Set used for?

  The Correct Flo Intravascular Administration Set is designed specifically for administering intravenous fluids, medications, or blood products directly into a patient’s vascular system. It ensures controlled fluid delivery while maintaining aseptic conditions, making it ideal for hospital or clinical environments where intravenous therapy is required. The set’s tubing and connectors are engineered to minimize contamination risks during use.

• Is the Correct Flo Intravascular Administration Set sterile and single-use?

  Yes, the Correct Flo Intravascular Administration Set is supplied as a sterile, single-use device. It must be discarded after one use to prevent contamination and ensure patient safety. This design adheres to best practices for intravenous therapy to avoid cross-contamination between patients.

• How is the Correct Flo Intravascular Administration Set regulated?

  The Correct Flo Intravascular Administration Set is regulated under the FDA’s 510(k) clearance process, with the clearance number K850506. It is classified as substantially equivalent to predicate devices and falls under FDA Product Code FPA, which categorizes it as an Intravascular Administration Set. This regulatory pathway ensures compliance with safety and performance standards for intravenous administration devices.

• What types of settings is this device intended for?

  This device is intended exclusively for use in hospital or clinical settings where intravenous therapy is administered. Its design supports controlled and aseptic fluid delivery, making it suitable for environments where patient safety and sterile procedures are critical. It is not intended for home use or non-clinical settings.

• Are there any special considerations for storage or handling?

  While the device data does not specify storage conditions, as a sterile, single-use product, it should be stored in a clean, dry environment protected from direct sunlight, moisture, and physical damage. Always follow manufacturer guidelines for unpacking and preparing the set before use to maintain sterility and functionality. Ensure the packaging remains intact until immediate use.