Cleared Traditional

K040901 - STERITEC EMU-GRAPH, MODEL NO. CI 131/US

K040901 is an FDA 510(k) clearance for STERITEC EMU-GRAPH, manufactured by Steritec Products, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K040901 · Steritec Products, Inc. · General Hospital
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Sep 2004
Decision
155d
Days
Class 2
Risk

K040901 is an FDA 510(k) clearance for the STERITEC EMU-GRAPH, MODEL NO. CI 131/US. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Steritec Products, Inc. (Castle Rock, US). The FDA issued a Cleared decision on September 9, 2004 after a review of 155 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 Steritec Products, Inc. devices

FDA 510(k) Submission Details - K040901

510(k) Number K040901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2004
Decision Date September 09, 2004
Days to Decision 155 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 129d · This submission: 155d
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 204
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K040901.
VERIFY FLASH INTEGRATOR
K051101 · Albert Browne , Ltd. · Dec 2005
SERIM PERACETIC ACID CHEMICAL INDICATOR
K052388 · Serim Research Corp. · Dec 2005
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · STERIS Corporation · Dec 2004
PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
K031152 · Propper Mfg. Co., Inc. · Aug 2004
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
K041017 · Spsmedical Supply Corp. · Jun 2004
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K040742 · Advanced Sterilization Products · Apr 2004