Cleared Traditional

K082765 - ASTOFLO PLUS

K082765 is an FDA 510(k) clearance for ASTOFLO PLUS, manufactured by Stihler Electronic GmbH. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K082765 · Stihler Electronic GmbH · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2008
Decision
87d
Days
Class 2
Risk

K082765 is an FDA 510(k) clearance for the ASTOFLO PLUS. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Stihler Electronic GmbH (Sound Beach, US). The FDA issued a Cleared decision on December 18, 2008 after a review of 87 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 Stihler Electronic GmbH devices

FDA 510(k) Submission Details - K082765

510(k) Number K082765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2008
Decision Date December 18, 2008
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 47
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K082765.
HYPOTHERMX INTRAVENOUS FLUID WARMER
K103801 · Emit Corporation · May 2011
AMSCO WARMING CABINET
K092823 · STERIS Corporation · Dec 2009
BELMONT HYPERTHERMIA PUMP
K090089 · Belmont Instrument Corp. · Feb 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
HYPERTHERMIA PUMP
K070654 · Belmont Instrument Corp. · Jun 2007
8NONE
K041839 · Medical Solutions, Inc. · Feb 2005