Cleared Traditional

K983194 - SPORICIDIN STERILIZING AND DISINFECTING...

K983194 is the FDA 510(k) clearance for SPORICIDIN STERILIZING AND DISINFECTING... by Sporicidin Intl.. It is a Class 2 General Hospital device (product code MED) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K983194 · Sporicidin Intl. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
175d
Days
Class 2
Risk

K983194 is an FDA 510(k) clearance for the SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS). Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Sporicidin Intl. (Rockville, US). The FDA issued a Cleared decision on March 5, 1999 after a review of 175 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 K983194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1998
Decision Date March 05, 1999
Days to Decision 175 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 129d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MED Sterilant, Medical Devices

All 29
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K983194.
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K960513 · Minntech Corp. · Oct 1997
CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE
K924334 · Johnson & Johnson Medical, Inc. · Mar 1994