QWIK-1 In-Line IV Fluid Warmer

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

Full name

Qwik-1(Tm) in-Line IV Fluid Warmer

510(k) Number

K914867 ↗

FDA Product Code

LGZ

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Xdcs-100

  Class II

  FDA 510(k) K932083 Active Cleared 16 Dec 1993

• Peritoneal Dialysis Stystem and Accessories

  Class II

  FDA 510(k) K900295 Active Cleared 21 Nov 1990

• PDM3 Disinfection System for Peritoneal Dialysis Exchanges, Patient Transfer Set PTS102, Cap, High Temperature

  Class II

  FDA 510(k) K974387 Active Cleared 1 Sep 1999

• Pdm-1 Device:capd Disinfecting Device, Modified

  Class II

  FDA 510(k) K913110 Active Cleared 10 Oct 1991

• What is the QWIK-1 In-Line IV Fluid Warmer used for?

  The QWIK-1 is a thermal device designed for warming infusion fluids within IV fluid delivery systems to maintain appropriate temperatures during administration in general hospital settings.

• How is the QWIK-1 In-Line IV Fluid Warmer supplied?

  The device is supplied by Microwave Medical Systems, Inc. and is intended for use in general hospital settings. It is a Class II medical device with FDA 510(k) clearance (K914867) and is registered under product code LGZ.

• Is the QWIK-1 In-Line IV Fluid Warmer reusable or single-use?

  The device data does not specify whether the QWIK-1 is designed for single-use or reuse. This information would need to be obtained directly from the manufacturer or product documentation.

• What are the regulatory requirements for the QWIK-1 In-Line IV Fluid Warmer?

  The QWIK-1 is a Class II medical device with FDA 510(k) clearance (K914867) and is registered under product code LGZ. It is intended for use in general hospital settings and has been determined to be substantially equivalent to predicate devices.