Cleared Traditional

INFU BOX TYPE 0412A (K120860) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120860 · Medical Rescue Equipment Holding AS · General Hospital
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May 2012
Decision
47d
Days
Class 2
Risk

K120860 is an FDA 510(k) clearance for the INFU BOX TYPE 0412A. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Medical Rescue Equipment Holding AS (Porsgrunn, NO). The FDA issued a Cleared decision on May 8, 2012 after a review of 47 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 Medical Rescue Equipment Holding AS devices

Submission Details

510(k) Number K120860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2012
Decision Date May 08, 2012
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 74
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K120860.
°M Warmer System with °M Station
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°M Warmer System
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Fluido Compact Blood and Fluid Warming System
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Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
K211800 · Quality IN Flow , Ltd. · Dec 2022