Cleared Special

K000502 - STEAM/EO RECORD CARD

K000502 is the FDA 510(k) clearance for STEAM/EO RECORD CARD by Steritec Products Mfg Co, Inc.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Special 510(k) pathway after a 28-day FDA review.

K000502 · Steritec Products Mfg Co, Inc. · General Hospital
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Mar 2000
Decision
28d
Days
Class 2
Risk

K000502 is an FDA 510(k) clearance for the STEAM/EO RECORD CARD, MODEL CI 121. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Steritec Products Mfg Co, Inc. (Castle Rock, US). The FDA issued a Cleared decision on March 14, 2000 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Steritec Products Mfg Co, Inc. devices

Submission Details

510(k) Number K000502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2000
Decision Date March 14, 2000
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 115
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K000502.
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K040742 · Advanced Sterilization Products · Apr 2004
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K022441 · Advanced Sterilization Products · Oct 2002
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · 3M Company · Apr 2002
KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP
K974415 · Kimberly-Clark Corp. · Jul 1998
STERRAD CHEMICAL INDICATOR TAPE
K945190 · Advanced Sterilization Products · Dec 1994
3M AUTOCLAVE TAPES
K932129 · 3M Company · Mar 1994