Cleared Traditional

K181775 - Quantum Blood and IV Fluid Infusion Warmer

K181775 is an FDA 510(k) clearance for Quantum Blood and IV Fluid Infusion Warmer, manufactured by Life Warmer, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K181775 · Life Warmer, Inc. · General Hospital
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Jan 2019
Decision
209d
Days
Class 2
Risk

K181775 is an FDA 510(k) clearance for the Quantum Blood and IV Fluid Infusion Warmer. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Life Warmer, Inc. (Plano, US). The FDA issued a Cleared decision on January 28, 2019 after a review of 209 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 Life Warmer, Inc. devices

FDA 510(k) Submission Details - K181775

510(k) Number K181775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2018
Decision Date January 28, 2019
Days to Decision 209 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 129d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 51
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K181775.
S-Line
K213191 · Barkey GmbH & Co. KG · May 2022
Quantum Blood and Fluid Warming System
K192325 · Life Warmer, Inc. · Oct 2019
MAC Medical D-Series Blanket and Solution Warming Cabinets
K180842 · Mac Medical, Inc. · Mar 2019
QiF Blood and Fluid Warmer
K180154 · Quality IN Flow , Ltd. · Apr 2018
QiF Blood and Fluid Warmer
K171215 · Quality IN Flow , Ltd. · Sep 2017
QiF Blood and Fluid Warmer
K163708 · Quality IN Flow , Ltd. · Apr 2017