Cleared Traditional

K944179 - CONTROL III DISINFECTANT GERMICIDE

K944179 is an FDA 510(k) clearance for CONTROL III DISINFECTANT GERMICIDE, manufactured by Maril Products, Inc.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K944179 · Maril Products, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
208d
Days
Class 1
Risk

K944179 is an FDA 510(k) clearance for the CONTROL III DISINFECTANT GERMICIDE. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Maril Products, Inc. (Tustin, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 208 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K944179

510(k) Number K944179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1994
Decision Date March 22, 1995
Days to Decision 208 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
79d slower than avg
Panel avg: 129d · This submission: 208d
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 K944179.
OCIDE HOSPITAL CLEANER-DISINFECTANT
K945227 · Clariant Corporation · Mar 1995
LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK
K940383 · National Laboratories · Mar 1995
DIACIDE HD DISINFECTING SOLUTION
K944037 · Gulfstream Medical · Mar 1995
MULTI-WASH
K950324 · Multi-Wash Medical, Ltd. · Mar 1995
COLDCIDE-10
K950516 · Metrex Research Corp. · Mar 1995
COLDCIDE-2
K950553 · Metrex Research Corp. · Mar 1995
K944179 · CONTROL III DISINFECTANT GERMICIDE
Download PDF FDA Summary Maril Products, Inc.