Cleared Traditional

K072408 - EMU-GRAPH EMULATOR

K072408 is the FDA 510(k) clearance for EMU-GRAPH EMULATOR by Steritec Products Mfg Co, Inc.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K072408 · Steritec Products Mfg Co, Inc. · General Hospital
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Apr 2008
Decision
247d
Days
Class 2
Risk

K072408 is an FDA 510(k) clearance for the EMU-GRAPH EMULATOR, MODEL CI 131. 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 April 30, 2008 after a review of 247 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 Mfg Co, Inc. devices

Submission Details

510(k) Number K072408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2007
Decision Date April 30, 2008
Days to Decision 247 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
118d slower than avg
Panel avg: 129d · This submission: 247d
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 115
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