Cleared Traditional

K960580 - BEAUCOUP GENERAL PURPOSE DISINFECTANT

K960580 is an FDA 510(k) clearance for BEAUCOUP GENERAL PURPOSE DISINFECTANT, manufactured by Huntington Laboratories, Inc.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K960580 · Huntington Laboratories, Inc. · General Hospital
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Mar 1996
Decision
29d
Days
Class 1
Risk

K960580 is an FDA 510(k) clearance for the BEAUCOUP GENERAL PURPOSE DISINFECTANT. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Huntington Laboratories, Inc. (Huntington, US). The FDA issued a Cleared decision on March 12, 1996 after a review of 29 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 Huntington Laboratories, Inc. devices

FDA 510(k) Submission Details - K960580

510(k) Number K960580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1996
Decision Date March 12, 1996
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 37
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K960580.
LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46)
K963353 · Reckitt Benckiser, Inc. · Oct 1996
T.B.Q.
K962739 · Convatec, A Division of E.R. Squibb & Sons · Oct 1996
DMS-9000
K960836 · O.R. Solutions, Inc. · Sep 1996
ASCEND GENERAL PURPOSE DISINFECTANT
K960582 · Huntington Laboratories, Inc. · Mar 1996
MATAR GENERAL PURPOSE DISINFECTANT
K960583 · Huntington Laboratories, Inc. · Mar 1996
PRO-TECH
K955850 · Central Solutions, Inc. · Feb 1996