Cleared Traditional

K922262 - SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT

K922262 is an FDA 510(k) clearance for SPORICIDIN BRAND DISINFECT TOWELETTES/S..., manufactured by Sporicidin Intl.. The device is a Class 1 General Hospital device with 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

FDA 510(k) Submission Details - K922262

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.

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 K922262.
LONZA FORMULATION R-82
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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