Cleared Traditional

K811136 - MUELLER HINTON BROTH

K811136 is an FDA 510(k) clearance for MUELLER HINTON BROTH, manufactured by Acumedia Manufacturers, Inc.. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K811136 · Acumedia Manufacturers, Inc. · Microbiology device
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May 1981
Decision
11d
Days
Class 2
Risk

K811136 is an FDA 510(k) clearance for the MUELLER HINTON BROTH. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Acumedia Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 5, 1981 after a review of 11 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 Acumedia Manufacturers, Inc. devices

FDA 510(k) Submission Details - K811136

510(k) Number K811136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1981
Decision Date May 05, 1981
Days to Decision 11 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
91d faster than avg
Panel avg: 102d · This submission: 11d
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 K811136.
MUELLER HINTON AGAR
K811471 · Biomedia, Inc. · Jun 1981
MUELLER HINTON AGAR, POURED INTO A PLATE
K811472 · Biomedia, Inc. · Jun 1981
MUELLER HINTON AGAR W/5% SHEEP BLOOD
K811473 · Biomedia, Inc. · Jun 1981
MUELLER HINTON AGAR
K811049 · Acumedia Manufacturers, Inc. · Apr 1981
MUELLER HINTON BROTH
K802957 · Gibco Laboratories Life Technologies, Inc. · Dec 1980
MUELLER HINTON AGAR
K802498 · Oxoid U.S.A., Inc. · Nov 1980