Cleared Traditional

K880105 - MULLER HINTON BROTH

K880105 is an FDA 510(k) clearance for MULLER HINTON BROTH, manufactured by Hardy Media. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K880105 · Hardy Media · Microbiology device
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Mar 1988
Decision
84d
Days
Class 2
Risk

K880105 is an FDA 510(k) clearance for the MULLER HINTON BROTH. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on March 30, 1988 after a review of 84 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 Hardy Media devices

FDA 510(k) Submission Details - K880105

510(k) Number K880105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1988
Decision Date March 30, 1988
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 102d · This submission: 84d
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 K880105.
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
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 SMALL
K864245 · Mds Laboratories, Inc. · Mar 1987