Cleared Traditional

K132202 - DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET (FDA 510(k) Clearance)

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

K132202 · Enthermics Medical Systems, Inc. · General Hospital
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Dec 2013
Decision
143d
Days
Class 2
Risk

K132202 is an FDA 510(k) clearance for the DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Enthermics Medical Systems, Inc. (Menomonee Falls, US). The FDA issued a Cleared decision on December 6, 2013 after a review of 143 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. 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 Enthermics Medical Systems, Inc. devices

Submission Details

510(k) Number K132202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2013
Decision Date December 06, 2013
Days to Decision 143 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
14d slower than avg
Panel avg: 129d · This submission: 143d
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 74
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K132202.
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