Cleared Special

K163708 - QiF Blood and Fluid Warmer

K163708 is an FDA 510(k) clearance for QiF Blood and Fluid Warmer, manufactured by Quality IN Flow , Ltd.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Special 510(k) pathway after a 112-day FDA review.

K163708 · Quality IN Flow , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
112d
Days
Class 2
Risk

K163708 is an FDA 510(k) clearance for the QiF Blood and Fluid Warmer. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Quality IN Flow , Ltd. (Kibutz Einat, IL). The FDA issued a Cleared decision on April 20, 2017 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Quality IN Flow , Ltd. devices

FDA 510(k) Submission Details - K163708

510(k) Number K163708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2016
Decision Date April 20, 2017
Days to Decision 112 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

LGZ Device Classification - Class 2, Special Controls

Product Code LGZ Warmer, Thermal, Infusion Fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LGZ Warmer, Thermal, Infusion Fluid

All 19
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K163708.
MAC Medical D-Series Blanket and Solution Warming Cabinets
K180842 · Mac Medical, Inc. · Mar 2019
Quantum Blood and IV Fluid Infusion Warmer
K181775 · Life Warmer, Inc. · Jan 2019
QiF Blood and Fluid Warmer
K180154 · Quality IN Flow , Ltd. · Apr 2018
ENFLOW IV FLUID WARMER
K112902 · Vital Signs, Inc. · Mar 2012
AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011
AMSCO WARMING CABINET
K110769 · STERIS Corporation · Jun 2011