Cleared Traditional

K132491 - MUELLER HINTON AGAR

K132491 is an FDA 510(k) clearance for MUELLER HINTON AGAR, manufactured by Edge Biologicals, Inc.. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K132491 · Edge Biologicals, Inc. · Microbiology device
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Jun 2014
Decision
326d
Days
Class 2
Risk

K132491 is an FDA 510(k) clearance for the MUELLER HINTON AGAR. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Edge Biologicals, Inc. (Memphis, US). The FDA issued a Cleared decision on June 30, 2014 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - the FDA microbiology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Edge Biologicals, Inc. devices

FDA 510(k) Submission Details - K132491

510(k) Number K132491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2013
Decision Date June 30, 2014
Days to Decision 326 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 102d · This submission: 326d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTZ Device Classification - Class 2, Special Controls

Product Code JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
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 Microbiology devices follow this clearance model.

Regulatory Peers - JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth

All 44
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K132491.
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
K963036 · Becton Dickinson Microbiology Systems · Oct 1996
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K960420 · Becton Dickinson Microbiology Systems · Apr 1996
MUELLER HINTON AGAR WITH 2% NACI
K960313 · Remel, L.P. · Mar 1996
MUELLER HINTON AGAR W/OXACILLIN
K941985 · Carr-Scarborough Microbiologicals, Inc. · Aug 1994
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
K882351 · Lakewood Biochemical Co., Inc. · Jun 1988
MULLER HINTON BROTH
K880105 · Hardy Media · Mar 1988