Cleared Traditional

K821430 - MUELLER HINTON MEDIUM

K821430 is the FDA 510(k) clearance for MUELLER HINTON MEDIUM by Interstate Media. It is a Class 2 Microbiology device (product code JTZ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K821430 · Interstate Media · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1982
Decision
20d
Days
Class 2
Risk

K821430 is an FDA 510(k) clearance for the MUELLER HINTON MEDIUM. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Interstate Media (Mchenry, US). The FDA issued a Cleared decision on June 1, 1982 after a review of 20 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 Interstate Media devices

Submission Details

510(k) Number K821430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1982
Decision Date June 01, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 102d · This submission: 20d
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 28
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K821430.
MUELLER HINTON
K830060 · bioMerieux, Inc. · Feb 1983
ACCESSORY MEDIA FOR FLOW TITERTEK MIC
K822119 · Flow Laboratories, Inc. · Aug 1982
MUELLER HINTON W/5% SHEEP'S BLOOD
K821607 · Hardy Media · Jul 1982
MUELLER HINTON AGAR
K811646 · Hardy Media · Jul 1981
MUELLER-HINTON
K811608 · Micro Media Laboratories · Jun 1981
MUELLER HINTON BROTH
K811136 · Acumedia Manufacturers, Inc. · May 1981