Cleared Traditional

K082217 - RANGER RAPID FLOW BLOOD/FLUID WARMING S...

K082217 is an FDA 510(k) clearance for RANGER RAPID FLOW BLOOD/FLUID WARMING S..., 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 61-day FDA review.

K082217 · Arizant Healthcare, Inc. · General Hospital
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Oct 2008
Decision
61d
Days
Class 2
Risk

K082217 is an FDA 510(k) clearance for the RANGER RAPID FLOW BLOOD/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 October 6, 2008 after a review of 61 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 - K082217

510(k) Number K082217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2008
Decision Date October 06, 2008
Days to Decision 61 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
68d faster than avg
Panel avg: 129d · This submission: 61d
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 19
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K082217.
AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011
AMSCO WARMING CABINET
K110769 · STERIS Corporation · Jun 2011
AMSCO WARMING CABINET
K092823 · STERIS Corporation · Dec 2009
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
K072080 · Smiths Medical Asd, Inc. · Jun 2008
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832 · Nxstage Medical, Inc. · Oct 2001
BT 794-BLOOD/FLUID WARMER
K822098 · Electromedics, Inc. · Aug 1982