Cleared Traditional

K122449 - ENTERAL NUTRITION WARMER

K122449 is an FDA 510(k) clearance for ENTERAL NUTRITION WARMER, manufactured by Acacia, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K122449

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
Combination Product No
PCCP Authorized No
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.

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 37
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K122449.
QiF Blood and Fluid Warmer
K180154 · Quality IN Flow , Ltd. · Apr 2018
QiF Blood and Fluid Warmer
K171215 · Quality IN Flow , Ltd. · Sep 2017
BELMONT HYPERTHERMIA PUMP
K131519 · Belmont Instrument Corp. · Nov 2013
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
K121775 · Vital Signs, Inc., A GE Healthcare Company · Nov 2012
BW685, BW685S
K121198 · Biegler GmbH · Jul 2012
PERFORMER HT/ HANG&GO HT BASIC
K120026 · Rand S.R.L. · May 2012