Cleared Traditional

K873268 - MUELLER HINTON MEDIA

K873268 is an FDA 510(k) clearance for MUELLER HINTON MEDIA, manufactured by Central Media. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K873268 · Central Media · Microbiology device
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Nov 1987
Decision
85d
Days
Class 2
Risk

K873268 is an FDA 510(k) clearance for the MUELLER HINTON MEDIA. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Central Media (Sacramento, US). The FDA issued a Cleared decision on November 4, 1987 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Central Media devices

FDA 510(k) Submission Details - K873268

510(k) Number K873268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1987
Decision Date November 04, 1987
Days to Decision 85 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 102d · This submission: 85d
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 31
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K873268.
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
MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.)
K870649 · Hardy Media · Apr 1987
CHOCOLATE MUELLER HINTON AGAR
K871097 · bioMerieux, Inc. · Apr 1987
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K863821 · Gibco Laboratories Life Technologies, Inc. · Oct 1986