Cleared Traditional

K850558 - CORN MEAL AGAR W/POLYSORBATE 80

K850558 is the FDA 510(k) clearance for CORN MEAL AGAR W/POLYSORBATE 80 by Hardy Media. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K850558 · Hardy Media · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
24d
Days
Class 1
Risk

K850558 is an FDA 510(k) clearance for the CORN MEAL AGAR W/POLYSORBATE 80, CORN MEAL W/POLYS. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on March 7, 1985 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 K850558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1985
Decision Date March 07, 1985
Days to Decision 24 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
78d faster than avg
Panel avg: 102d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JSG Culture Media, Non-selective And Non-differential

All 175
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K850558.
THIOGLYCOLATE MEDIUM W/VITAMIN KL & HEMIN
K850847 · Micro Media Laboratories · Mar 1985
BRAIN HEART INFUSION AGAR
K850848 · Micro Media Laboratories · Mar 1985
TODD HEWITT BROTH
K850549 · Hardy Media · Mar 1985
THIOGLYCOLLATE W/O DEXTROSE OR INDICATOR
K844526 · bioMerieux, Inc. · Jan 1985
NUTRIENT BROTH
K844528 · bioMerieux, Inc. · Jan 1985
BRAIN HEART INFUSION BROTH
K844529 · bioMerieux, Inc. · Jan 1985