Cleared Abbreviated

K113302 - NAMSA STEAM SELF-CONTAINED BIOLOGICAL I...

K113302 is an FDA 510(k) clearance for NAMSA STEAM SELF-CONTAINED BIOLOGICAL I..., manufactured by North American Science Assoc., Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Abbreviated 510(k) pathway after a 73-day FDA review.

K113302 · North American Science Assoc., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
73d
Days
Class 2
Risk

K113302 is an FDA 510(k) clearance for the NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by North American Science Assoc., Inc. (Toledo, US). The FDA issued a Cleared decision on January 20, 2012 after a review of 73 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all North American Science Assoc., Inc. devices

FDA 510(k) Submission Details - K113302

510(k) Number K113302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2011
Decision Date January 20, 2012
Days to Decision 73 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Standards-based clearance path.

FRC Device Classification - Class 2, Special Controls

Product Code FRC Indicator, Biological 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 - FRC Indicator, Biological Sterilization Process

All 148
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