Cleared Traditional

K122449 - ENTERAL NUTRITION WARMER

K122449 is the FDA 510(k) clearance for ENTERAL NUTRITION WARMER by Acacia, Inc.. It is a Class 2 General Hospital device (product code LGZ) cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K122449 · Acacia, Inc. · General Hospital
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Jun 2013
Decision
304d
Days
Class 2
Risk

K122449 is an FDA 510(k) clearance for the ENTERAL NUTRITION WARMER. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Acacia, Inc. (Brea, US). The FDA issued a Cleared decision on June 13, 2013 after a review of 304 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 Acacia, Inc. devices

Submission Details

510(k) Number K122449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2012
Decision Date June 13, 2013
Days to Decision 304 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
175d slower than avg
Panel avg: 129d · This submission: 304d
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 K122449.
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
ENFLOW IV FLUID WARMER
K112902 · Vital Signs, Inc. · Mar 2012
AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011
AMSCO WARMING CABINET
K110769 · STERIS Corporation · Jun 2011