Cleared Traditional

SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT (K922262) - FDA 510(k) Clearance

Class I General Hospital device.

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.