Cleared Traditional

K041839 - 8NONE

K041839 is an FDA 510(k) clearance for 8NONE, manufactured by Medical Solutions, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K041839 · Medical Solutions, Inc. · General Hospital
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Feb 2005
Decision
222d
Days
Class 2
Risk

K041839 is an FDA 510(k) clearance for the 8NONE. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Medical Solutions, Inc. (Crofton, US). The FDA issued a Cleared decision on February 15, 2005 after a review of 222 days - an extended review cycle.

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 - K041839

510(k) Number K041839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2004
Decision Date February 15, 2005
Days to Decision 222 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 129d · This submission: 222d
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 K041839.
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
K052055 · Smisson-Cartledge Biomedical, LLC · Oct 2006
RANGER IRRIGATION FLUID WARMING SYSTEM
K060939 · Arizant Healthcare, Inc. · Jun 2006
EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
K060537 · Enginivity, LLC · Jun 2006
LARGE VOLUME FLUID RESERVOIR
K032778 · Belmont Instrument Corp. · Sep 2003
BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
K032674 · Belmont Instrument Corp. · Sep 2003
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
K031390 · Minimed, Inc. · Jul 2003
K041839 · 8NONE
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