Cleared Traditional

K950553 - COLDCIDE-2

K950553 is an FDA 510(k) clearance for COLDCIDE-2, manufactured by Metrex Research Corp.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K950553 · Metrex Research Corp. · General Hospital
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Mar 1995
Decision
43d
Days
Class 1
Risk

K950553 is an FDA 510(k) clearance for the COLDCIDE-2. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Metrex Research Corp. (Parker, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6890 - 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 - K950553

510(k) Number K950553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1995
Decision Date March 22, 1995
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

LRJ Device Classification - Class 1, General Controls

Product Code LRJ Disinfectant, Medical Devices
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6890
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LRJ Disinfectant, Medical Devices

All 72
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K950553.
CONTROL III DISINFECTANT GERMICIDE
K944179 · Maril Products, Inc. · Mar 1995
MULTI-WASH
K950324 · Multi-Wash Medical, Ltd. · Mar 1995
COLDCIDE-10
K950516 · Metrex Research Corp. · Mar 1995
LYSOL I.C. BRAND QUATERNARY CLEANER DISINFECTANT
K940381 · National Laboratories · Jul 1994
LYSOL I.C. BRAND DISINFECTANT SPRAY
K940400 · L&F Products · Jul 1994
AMERSE
K931477 · Calgon Vestal Div. · Jun 1994
K950553 · COLDCIDE-2
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