Cleared Traditional

K141238 - STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR

K141238 is an FDA 510(k) clearance for STERILUCENT SELF-CONTAINED BIOLOGICAL I..., manufactured by Sterilucent, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K141238 · Sterilucent, Inc. · General Hospital
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Nov 2014
Decision
174d
Days
Class 2
Risk

K141238 is an FDA 510(k) clearance for the STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Sterilucent, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 3, 2014 after a review of 174 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 Sterilucent, Inc. devices

FDA 510(k) Submission Details - K141238

510(k) Number K141238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2014
Decision Date November 03, 2014
Days to Decision 174 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 129d · This submission: 174d
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 K141238.
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K151971 · Advanced Sterilization Products · Oct 2015
STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
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K140589 · Mesa Laboratories, Inc. · Dec 2014
STERILUCENT PROCESS CHALLENGE DEVICE
K141312 · Sterilucent, Inc. · Oct 2014
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)
K141244 · North American Science Assoc., Inc. · Sep 2014
STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K133549 · Steritec Products Mfg Co, Inc. · Aug 2014