Cleared Traditional

K946078 - HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT

K946078 is an FDA 510(k) clearance for HOSPITAL BROAD BAND CLEANDR - DISINFECT..., manufactured by Clariant Corporation. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K946078 · Clariant Corporation · General Hospital
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Mar 1995
Decision
101d
Days
Class 1
Risk

K946078 is an FDA 510(k) clearance for the HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Clariant Corporation (Wilmington, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 101 days - within the typical 510(k) review window.

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.

View all Clariant Corporation devices

FDA 510(k) Submission Details - K946078

510(k) Number K946078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1994
Decision Date March 24, 1995
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
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 38
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K946078.
KLORMAN
K923693 · Matrix Medica, Inc. · Jan 1996
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
K934014 · Biotrol, USA, Inc. · Dec 1995
RENALIN COLD STERILANT
K941439 · Minntech Corp. · Jun 1995
AMERSE
K931477 · Calgon Vestal Div. · Jun 1994
LPH
K931342 · Calgon Vestal Div. · May 1994
VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM
K931816 · Calgon Vestal Div. · May 1994