Cleared Traditional

K003087 - MODIFICATION TO SPORICIDIN STERILIZING ...

K003087 is the FDA 510(k) clearance for MODIFICATION TO SPORICIDIN STERILIZING ... by Sporicidin Intl.. It is a Class 2 General Hospital device (product code MED) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K003087 · Sporicidin Intl. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
41d
Days
Class 2
Risk

K003087 is an FDA 510(k) clearance for the MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION. 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 November 7, 2000 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sporicidin Intl. devices

Submission Details

510(k) Number K003087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2000
Decision Date November 07, 2000
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 K003087.
RESERT XL HLD HIGH LEVEL DISINFECTANT
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CIDEX OPA CONCENTRATE
K032959 · Advanced Sterilization Products · Apr 2005
0.55% ORTH-PHTHALALDEHYDE SOLUTION
K030004 · Advanced Sterilization Products · Feb 2003
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
K002401 · Advanced Sterilization Products · Aug 2000
CIDEX OPA SOLUTION
K001381 · Advanced Sterilization Products · May 2000
CIDEX OPA SOLUTION
K991487 · Advanced Sterilization Products · Oct 1999