Cleared Traditional

TRYPTIC SOY BROTH (K851601) - FDA 510(k) Clearance

Class I Microbiology device.

K851601 · Preferred Micro-Media · Microbiology device
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May 1985
Decision
22d
Days
Class 1
Risk

K851601 is an FDA 510(k) clearance for the TRYPTIC SOY BROTH. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Preferred Micro-Media (Toledo, US). The FDA issued a Cleared decision on May 8, 1985 after a review of 22 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 Preferred Micro-Media devices

Submission Details

510(k) Number K851601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date May 08, 1985
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
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 208
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K851601.
DEXTROSE AGAR
K881522 · Acumedia Manufacturers, Inc. · Apr 1988
DEXTROSE TRYPTONE BROTH
K881523 · Acumedia Manufacturers, Inc. · Apr 1988
COOKED MEAT MEDIUM
K881525 · Acumedia Manufacturers, Inc. · Apr 1988
CASEIN PEPTONE, LOW VITAMIN
K881528 · Acumedia Manufacturers, Inc. · Apr 1988
BLOOD AGAR BASE, IMPROVED
K881531 · Acumedia Manufacturers, Inc. · Apr 1988
BLOOD AGAR BASE W/LOW PH
K881532 · Acumedia Manufacturers, Inc. · Apr 1988