Cleared Traditional

K850553 - MUELLER HINTON AGAR W/CHOCOLATE

K850553 is the FDA 510(k) clearance for MUELLER HINTON AGAR W/CHOCOLATE by Hardy Media. It is a Class 2 Microbiology device (product code JTZ) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K850553 · Hardy Media · Microbiology device
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Mar 1985
Decision
28d
Days
Class 2
Risk

K850553 is an FDA 510(k) clearance for the MUELLER HINTON AGAR W/CHOCOLATE, MH W/CHOC. 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 11, 1985 after a review of 28 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

Submission Details

510(k) Number K850553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1985
Decision Date March 11, 1985
Days to Decision 28 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
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K850553.
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K863821 · Gibco Laboratories Life Technologies, Inc. · Oct 1986
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
K850291 · Remel Co. · May 1985
MUELLER HINTON CHOCOLATE AGAR
K850843 · Micro Media Laboratories · Mar 1985
MUELLER-HINTON BROTH
K841560 · Gibco Laboratories Life Technologies, Inc. · May 1984
MUELLER HINTON AGAR W/BLOOD & COFACTOR
K841138 · Anaerobe Systems · Apr 1984
MUELLER HINTON AGAR W/WO BLOOD
K841137 · Anaerobe Systems · Mar 1984