Tempo and Temp H20

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

510(k) Number

K973748 ↗

FDA Product Code

LGZ

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Protective Restraint Models #302, 440, 750, 850, AND905

  Class I

  FDA 510(k) K972123 Active Cleared 25 Jul 1997

• Qa-Es

  Class II

  FDA 510(k) K971092 Active Cleared 23 Apr 1997

• Controlled Temperature Cabinet System

  Not classified

  FDA 510(k) K973747 Active Cleared 7 May 1998

• IL0292 Dp Echoport

  Class II

  FDA 510(k) K970555 Active Cleared 17 Mar 1997

• What is the Tempo and Temp H2O used for?

  The Tempo and Temp H2O is a Thermal Infusion Fluid Warmer designed to heat intravenous fluids to a safe and consistent temperature before administration. This helps minimize patient discomfort and reduces risks such as vasoconstriction or metabolic disturbances caused by cold infusions. It is intended for use in clinical settings like hospitals and outpatient care.

• Is the Tempo and Temp H2O single-use or reusable?

  The Tempo and Temp H2O is explicitly designed for single-use only. This ensures sterility and safety for each procedure, adhering to standard sterile medical device protocols. Reusable components are not indicated or included in the device.

• How should the Tempo and Temp H2O be stored?

  The device must be stored and handled according to standard sterile medical device protocols to maintain its efficacy and safety. Since it is single-use and sterile upon supply, it should be kept in its original packaging until ready for immediate use, following manufacturer guidelines to prevent contamination.

• What regulatory pathway does the Tempo and Temp H2O follow?

  The Tempo and Temp H2O is regulated under the FDA’s Traditional 510(k) pathway with clearance number K973748. It is classified as a Class 2 medical device under the General Hospital category (product code LGZ) and adheres to 21 CFR 880.5725. This pathway ensures the device meets safety and performance standards for thermal infusion fluid warmers.

• Can the Tempo and Temp H2O be used with MRI equipment?

  The device does not specify any MRI safety information, meaning its compatibility with MRI environments has not been evaluated or certified. Clinicians should verify compatibility with their specific MRI systems before use to avoid potential interference or safety risks.