Cleared Traditional

K132202 - DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET

K132202 is an FDA 510(k) clearance for DC SERIES FLUID WARMING CABINET, manufactured by Enthermics Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K132202 · Enthermics Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K132202

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
Combination Product No
PCCP Authorized No
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.

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 72
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K132202.
QiF Blood and Fluid Warmer
K150404 · Quality IN Flow , Ltd. · Jun 2016
The Belmont Hyperthermia Pump
K152208 · Belmont Instrument Corporation · Sep 2015
Penguin In-Line Warmer
K150484 · Creche Innovations · Jul 2015
BELMONT HYPERTHERMIA PUMP
K131519 · Belmont Instrument Corp. · Nov 2013
NATUS WARMETTE BLANKET AND DUAL CABINETS
K132110 · Natus Nicolet Ireland, Ltd. · Oct 2013
ENFLOW IV FLUID WARMER INSULATED STRAP
K130867 · Vital Signs, Inc., A GE Healthcare Company · Jun 2013
K132202 · DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
Download PDF FDA Summary Enthermics Medical Sy…