Cleared Traditional

QiF Blood and Fluid Warmer (K171215) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171215 · Quality IN Flow , Ltd. · General Hospital
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Sep 2017
Decision
155d
Days
Class 2
Risk

K171215 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 September 27, 2017 after a review of 155 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Quality IN Flow , Ltd. devices

Submission Details

510(k) Number K171215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2017
Decision Date September 27, 2017
Days to Decision 155 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 15
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K171215.
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
AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011
AMSCO WARMING CABINET
K110769 · STERIS Corporation · Jun 2011
AMSCO WARMING CABINET
K092823 · STERIS Corporation · Dec 2009