Cleared Traditional

K120860 - INFU BOX TYPE 0412A

K120860 is an FDA 510(k) clearance for INFU BOX TYPE 0412A, manufactured by Medical Rescue Equipment Holding AS. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K120860 · Medical Rescue Equipment Holding AS · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K120860

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
Combination Product No
PCCP Authorized No
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.

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 73
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K120860.
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
K121775 · Vital Signs, Inc., A GE Healthcare Company · Nov 2012
BW685, BW685S
K121198 · Biegler GmbH · Jul 2012
PERFORMER HT/ HANG&GO HT BASIC
K120026 · Rand S.R.L. · May 2012
IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS
K112702 · Imperial Surgical , Ltd. · Mar 2012
HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
K102900 · Hei, Inc. · Mar 2012
ENFLOW IV FLUID WARMER
K112902 · Vital Signs, Inc. · Mar 2012
K120860 · INFU BOX TYPE 0412A
Download PDF FDA Summary Medical Rescue Equipm…