Cleared Traditional

K882361 - STIHLER ASTOTHERM IFT 200, IFT 220

K882361 is an FDA 510(k) clearance for STIHLER ASTOTHERM IFT 200, manufactured by Stihler Electronic, C/O Worldwide Regul. Services. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K882361 · Stihler Electronic, C/O Worldwide Regul. Services · General Hospital
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Aug 1988
Decision
79d
Days
Class 2
Risk

K882361 is an FDA 510(k) clearance for the STIHLER ASTOTHERM IFT 200, IFT 220. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Stihler Electronic, C/O Worldwide Regul. Services (Farmingville, US). The FDA issued a Cleared decision on August 25, 1988 after a review of 79 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, C/O Worldwide Regul. Services devices

FDA 510(k) Submission Details - K882361

510(k) Number K882361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1988
Decision Date August 25, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 129d · This submission: 79d
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.