Cleared Traditional

K060939 - RANGER IRRIGATION FLUID WARMING SYSTEM

K060939 is an FDA 510(k) clearance for RANGER IRRIGATION FLUID WARMING SYSTEM, manufactured by Arizant Healthcare, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K060939 · Arizant Healthcare, Inc. · General Hospital
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Jun 2006
Decision
81d
Days
Class 2
Risk

K060939 is an FDA 510(k) clearance for the RANGER IRRIGATION FLUID WARMING SYSTEM. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Arizant Healthcare, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on June 26, 2006 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arizant Healthcare, Inc. devices

FDA 510(k) Submission Details - K060939

510(k) Number K060939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2006
Decision Date June 26, 2006
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
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 65
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K060939.
HYPERTHERMIA PUMP
K070654 · Belmont Instrument Corp. · Jun 2007
SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER
K060851 · The Smithworks Company · Dec 2006
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
K052055 · Smisson-Cartledge Biomedical, LLC · Oct 2006
EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
K060537 · Enginivity, LLC · Jun 2006
8NONE
K041839 · Medical Solutions, Inc. · Feb 2005
LARGE VOLUME FLUID RESERVOIR
K032778 · Belmont Instrument Corp. · Sep 2003