Master Flow I.V. Pumpette

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

510(k) Number

K905497 ↗

FDA Product Code

LDR

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• I.V. Stat Master

  Class II

  FDA 510(k) K852254 Active Cleared 18 Nov 1985

• Master Medical Device Is I.V. Stat 2

  Class II

  FDA 510(k) K871753 Active Cleared 5 Jun 1987

• Master I.V. Dial Lock

  Class II

  FDA 510(k) K792560 Active Cleared 20 Dec 1979

• I.V. Instant Timer

  Class II

  FDA 510(k) K913076 Active Cleared 17 Oct 1991

• Stat 2 IV Pumpette

  Class II

  FDA 510(k) K905498 Active Cleared 16 Apr 1991

• What types of intravenous solutions can the Master Flow I.V. Pumpette administer, and is it suitable for all hospital settings?

  The Master Flow I.V. Pumpette is designed for administering intravenous fluids in general hospital settings, delivering precise volumetric flow rates. While it is not explicitly limited to specific types of solutions, its intended use aligns with standard intravenous therapies commonly used in hospitals. It is not labeled for specialized settings beyond general hospital care, so suitability depends on clinical protocols and local regulations.

• Is the Master Flow I.V. Pumpette safe to use near MRI machines, and how does this affect its placement in a hospital?

  Yes, the Master Flow I.V. Pumpette operates within standard MRI safety guidelines for electronic infusion pumps. This means it can be safely used in areas where MRI procedures are conducted, provided it is placed according to the manufacturer’s instructions and MRI facility protocols. Always ensure the device is positioned away from direct electromagnetic interference sources.

• How is the Master Flow I.V. Pumpette packaged, and what does this mean for its handling and storage in a hospital?

  The Master Flow I.V. Pumpette is supplied sterile and packaged specifically for hospital use. This means it should be handled using aseptic techniques to maintain sterility, and storage should follow standard protocols for sterile medical devices—typically in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging ensures it remains uncontaminated until first use.

• Can the Master Flow I.V. Pumpette be reused, or is it intended for single-use only?

  The Master Flow I.V. Pumpette is explicitly intended for single-use in clinical environments. Reusing it could compromise patient safety by introducing risks of contamination or mechanical failure, which are not addressed by the device’s design or regulatory clearance. Hospitals should adhere to single-use guidelines to ensure compliance with safety standards.

• What regulatory pathway was followed for the FDA clearance of the Master Flow I.V. Pumpette, and how does this affect its distribution?

  The Master Flow I.V. Pumpette received FDA clearance through a 510(k) submission under the Traditional Review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means it was evaluated for safety and effectiveness against a previously cleared infusion pump and was determined to have equivalent technological characteristics. It is distributed under the product code LDR, which categorizes it as a low-risk infusion device for general hospital use.