Cleared Traditional

K133322 - STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

K133322 is an FDA 510(k) clearance for STERITEC SMART-READ BIOLOGICAL TEST PAC..., manufactured by Steritec Products Mfg Co, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K133322 · Steritec Products Mfg Co, Inc. · General Hospital
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Aug 2014
Decision
300d
Days
Class 2
Risk

K133322 is an FDA 510(k) clearance for the STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Steritec Products Mfg Co, Inc. (Engelwood, US). The FDA issued a Cleared decision on August 25, 2014 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K133322

510(k) Number K133322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2013
Decision Date August 25, 2014
Days to Decision 300 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 129d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K133322.
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K140392 · 3M Company · Aug 2014
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K140499 · STERIS Corporation · Jul 2014