Cleared Traditional

K922262 - SPORICIDIN BRAND DISINFECT TOWELETTES/S...

K922262 is the FDA 510(k) clearance for SPORICIDIN BRAND DISINFECT TOWELETTES/S... by Sporicidin Intl.. It is a Class 1 General Hospital device (product code LRJ) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K922262 · Sporicidin Intl. · General Hospital

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Sep 1992

Decision

126d

Days

Class 1

Risk

K922262 is an FDA 510(k) clearance for the SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT. 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 September 15, 1992 after a review of 126 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 Sporicidin Intl. devices

Submission Details

510(k) Number	K922262 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	May 12, 1992
Decision Date	September 15, 1992
Days to Decision	126 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

3d faster than avg

Panel avg: 129d · This submission: 126d

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 K922262.

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K922262

Sporicidin Intl.

Rockville, MD · US

HAROLD E PLANK

Regulatory profile

8 submissions 7 cleared

88% clearance rate · Active in General Hospital

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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