Cleared Traditional

K963353 - LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46)

K963353 is an FDA 510(k) clearance for LYSOL I.C. BRAND PHENOLIC DISINFECTANT ..., manufactured by Reckitt Benckiser, Inc.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K963353 · Reckitt Benckiser, Inc. · General Hospital
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Oct 1996
Decision
53d
Days
Class 1
Risk

K963353 is an FDA 510(k) clearance for the LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46). Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Reckitt Benckiser, Inc. (Montvale, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 53 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.

View all Reckitt Benckiser, Inc. devices

FDA 510(k) Submission Details - K963353

510(k) Number K963353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1996
Decision Date October 18, 1996
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 23
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K963353.
TRIAD II DISINFECTANT CLEANER AND DEODORANT
K964610 · S.C. Johnson & Son, Inc. · Dec 1996
VIREX II 256 GERMICIDAL CLEANER AND DEODORANT
K964613 · S.C. Johnson & Son, Inc. · Dec 1996
COVERAGE HBV
K964749 · Convatec, A Division of E.R. Squibb & Sons · Dec 1996
T.B.Q.
K962739 · Convatec, A Division of E.R. Squibb & Sons · Oct 1996
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
K934014 · Biotrol, USA, Inc. · Dec 1995
RENALIN COLD STERILANT
K941439 · Minntech Corp. · Jun 1995