Cleared Special

QiF Blood and Fluid Warmer

K180154 · Quality IN Flow , Ltd. · General Hospital
Apr 2018
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K180154 is an FDA 510(k) clearance for the QiF Blood and Fluid Warmer, a Warmer, Thermal, Infusion Fluid (Class II — Special Controls, product code LGZ), submitted by Quality IN Flow , Ltd. (Kibutz Einat, IL). The FDA issued a Cleared decision on April 27, 2018, 98 days after receiving the submission on January 19, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K180154 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2018
Decision Date April 27, 2018
Days to Decision 98 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LGZ — Warmer, Thermal, Infusion Fluid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

Similar Devices — LGZ Warmer, Thermal, Infusion Fluid

All 73
Fluido Compact System
K252636 · The Surgical Company International B.V. · Nov 2025
Fluido? AirGuard System
K251733 · The Surgical Company International BV (As Tsc Life) · Sep 2025
?M Warmer System
K232107 · Mequ A/S · May 2024
Fluido Compact Blood and Fluid Warming System
K211618 · The Surgical Company International B.V. · Jun 2023
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
K211800 · Quality IN Flow , Ltd. · Dec 2022
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
K202461 · Smisson-Cartledge Biomedical, LLC · Aug 2022