Cleared Traditional

K181775 - Quantum Blood and IV Fluid Infusion Warmer

K181775 is the FDA 510(k) clearance for Quantum Blood and IV Fluid Infusion Warmer by Life Warmer, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

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 18
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
ENFLOW IV FLUID WARMER
K112902 · Vital Signs, Inc. · Mar 2012
AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011