Cleared Traditional

K020409 - STEAMPLUS STERILIZATION TEST

K020409 is an FDA 510(k) clearance for STEAMPLUS STERILIZATION TEST, manufactured by Spsmedical Supply Corp.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K020409 · Spsmedical Supply Corp. · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K020409

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
Combination Product No
PCCP Authorized No
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.

JOJ Device Classification - Class 2, Special Controls

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 227
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K020409.
MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K032801 · Albert Browne , Ltd. · Oct 2003
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
K030680 · Spsmedical Supply Corp. · May 2003
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K022441 · Advanced Sterilization Products · Oct 2002
BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK
K002741 · Albert Browne , Ltd. · Jul 2002
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · 3M Company · Apr 2002
BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS
K012335 · Albert Browne , Ltd. · Oct 2001