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Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6, Ivnow Modular Fluid Warmer 230V

by Enthermics Medical Systems, Inc.

510(k) K091336

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091336 Date7 May 2010ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LGZ
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IVNow Modular Fluid Warmer is a thermal infusion fluid warmer designed to rapidly heat and maintain the temperature of intravenous (IV) and irrigation fluids. It employs modular warming modules to ensure precise temperature control, enhancing patient safety by reducing the risk of hypothermia during fluid administration. The device is classified as a Class II thermal warmer under FDA regulations and is intended for use in general hospital settings.

The IVNow Modular Fluid Warmer is supplied as a reusable medical device and is intended for use in clinical environments such as operating rooms, intensive care units, and emergency departments. Available in both 120V and 230V configurations, it features multiple models (IVNow-1, IVNow-2, IVNow-3, IVNow-6) to accommodate single, dual, or triple bag systems. The device has received FDA 510(k) clearance under the Traditional pathway and is regulated under the classification number 880.5725. It is not MRI-safe and requires proper storage in a clean, dry environment.

Other devices from Enthermics Medical Systems, Inc.

Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical settings is the IVNow Modular Fluid Warmer designed for, and how does its modular design benefit patient care?

    The IVNow Modular Fluid Warmer is designed for use in general hospital environments, including operating rooms, intensive care units, and emergency departments. Its modular warming modules allow precise temperature control of intravenous and irrigation fluids, which helps reduce the risk of patient hypothermia during fluid administration. This modular approach accommodates different clinical workflows by supporting single, dual, or triple bag systems, depending on the model (IVNow-1, IVNow-2, IVNow-3, or IVNow-6).

  • Is the IVNow Modular Fluid Warmer single-use or reusable, and what storage conditions should be followed?

    The IVNow Modular Fluid Warmer is a reusable medical device, meaning it is intended for repeated use in clinical settings after proper cleaning and maintenance. To ensure optimal performance and safety, it should be stored in a clean, dry environment, away from direct sunlight or moisture, to prevent damage or contamination.

  • What voltage options are available for the IVNow Modular Fluid Warmer, and how does this affect its compatibility with different healthcare facilities?

    The IVNow Modular Fluid Warmer is available in both 120V and 230V configurations, making it compatible with electrical systems in various regions and healthcare facilities worldwide. This dual-voltage capability ensures flexibility for hospitals and clinics with different power standards, reducing the need for additional adapters or conversions.

  • How does the FDA clearance process apply to this device, and what does the classification number 880.5725 indicate?

    The IVNow Modular Fluid Warmer received FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be *substantially equivalent* to a legally marketed device already on the market. The classification number 880.5725 identifies it as a Class II thermal infusion fluid warmer, regulated under general hospital use guidelines. This classification reflects its role in maintaining precise fluid temperatures to enhance patient safety.