Cleared Traditional

STEAMPLUS STERILIZATION TEST (K020409) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020409 · Spsmedical Supply Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2002
Decision
161d
Days
Class 2
Risk

K020409 is an FDA 510(k) clearance for the STEAMPLUS STERILIZATION TEST. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Spsmedical Supply Corp. (Rush, US). The FDA issued a Cleared decision on July 18, 2002 after a review of 161 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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 Spsmedical Supply Corp. devices

Submission Details

510(k) Number K020409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2002
Decision Date July 18, 2002
Days to Decision 161 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
32d slower than avg
Panel avg: 129d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 - JOJ Indicator, Physical/chemical Sterilization Process

All 96
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K020409.
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K070461 · STERIS Corporation · Jul 2007
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3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · 3M Company · Apr 2002
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K932129 · 3M Company · Mar 1994
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K895422 · Baxter Healthcare Corp · Nov 1989