Cleared Traditional

K180842 - MAC Medical D-Series Blanket and Soluti...

K180842 is the FDA 510(k) clearance for MAC Medical D-Series Blanket and Soluti... by Mac Medical, Inc.. It is a Class 2 General Hospital device (product code LGZ) cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K180842 · Mac Medical, Inc. · General Hospital
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Mar 2019
Decision
340d
Days
Class 2
Risk

K180842 is an FDA 510(k) clearance for the MAC Medical D-Series Blanket and Solution Warming Cabinets. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Mac Medical, Inc. (Millstadt, US). The FDA issued a Cleared decision on March 5, 2019 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mac Medical, Inc. devices

Submission Details

510(k) Number K180842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2018
Decision Date March 05, 2019
Days to Decision 340 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
211d slower than avg
Panel avg: 129d · This submission: 340d
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 K180842.
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
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Quantum Blood and Fluid Warming System
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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