Cleared Traditional

K904580 - SPORICIDIN BRAND DISINFECTANT SPRAY

K904580 is the FDA 510(k) clearance for SPORICIDIN BRAND DISINFECTANT SPRAY by Sporicidin Intl.. It is a Class 1 General Hospital device (product code LRJ) cleared through the Traditional 510(k) pathway after a 587-day FDA review.

K904580 · Sporicidin Intl. · General Hospital
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May 1992
Decision
587d
Days
Class 1
Risk

K904580 is an FDA 510(k) clearance for the SPORICIDIN BRAND DISINFECTANT SPRAY. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Sporicidin Intl. (Rockville, US). The FDA issued a Cleared decision on May 18, 1992 after a review of 587 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Sporicidin Intl. devices

Submission Details

510(k) Number K904580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1990
Decision Date May 18, 1992
Days to Decision 587 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
458d slower than avg
Panel avg: 129d · This submission: 587d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 12
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K904580.
RENALIN COLD STERILANT
K941439 · Minntech Corp. · Jun 1995
CIDEX PLUS 28 DAY SOLUTION
K923744 · Johnson & Johnson Medical, Inc. · Mar 1994
CIDEX ACTIVATED DIALDEHYDE SOLUTION
K924434 · Johnson & Johnson Medical, Inc. · Mar 1994
RENALIN COLD STERILANT
K882564 · Minntech Corp. · Jan 1989
CLEANING SOLUTION, CATALOG NO. 8203
K870759 · Treace Medical, Inc. · May 1987