Cleared Traditional

K150484 - Penguin In-Line Warmer

K150484 is an FDA 510(k) clearance for Penguin In-Line Warmer, manufactured by Creche Innovations. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K150484 · Creche Innovations · General Hospital
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Jul 2015
Decision
135d
Days
Class 2
Risk

K150484 is an FDA 510(k) clearance for the Penguin In-Line Warmer. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Creche Innovations (Stilwell, US). The FDA issued a Cleared decision on July 9, 2015 after a review of 135 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 Creche Innovations devices

FDA 510(k) Submission Details - K150484

510(k) Number K150484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2015
Decision Date July 09, 2015
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 25
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K150484.
MAC Medical D-Series Blanket and Solution Warming Cabinets
K180842 · Mac Medical, Inc. · Mar 2019
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
BELMONT HYPERTHERMIA PUMP
K131519 · Belmont Instrument Corp. · Nov 2013
ENFLOW IV FLUID WARMER
K112902 · Vital Signs, Inc. · Mar 2012
AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011