Cleared Traditional

K133549 - STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

K133549 is an FDA 510(k) clearance for STERITEC BIOLOGICAL TEST PACK WITH INST..., 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 281-day FDA review.

K133549 · Steritec Products Mfg Co, Inc. · General Hospital
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Aug 2014
Decision
281d
Days
Class 2
Risk

K133549 is an FDA 510(k) clearance for the STERITEC 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 27, 2014 after a review of 281 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

FDA 510(k) Submission Details - K133549

510(k) Number K133549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2013
Decision Date August 27, 2014
Days to Decision 281 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
152d slower than avg
Panel avg: 129d · This submission: 281d
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 K133549.
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