Cleared Traditional

K792288 - TRYPTONE BROTH (TRYPTOPHANE BROTH)

K792288 is the FDA 510(k) clearance for TRYPTONE BROTH (TRYPTOPHANE BROTH) by Isle Media and Sterile Products, Inc.. It is a Class 1 Microbiology device (product code JSH) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K792288 · Isle Media and Sterile Products, Inc. · Microbiology device
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Dec 1979
Decision
36d
Days
Class 1
Risk

K792288 is an FDA 510(k) clearance for the TRYPTONE BROTH (TRYPTOPHANE BROTH). Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Isle Media and Sterile Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 19, 1979 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 Isle Media and Sterile Products, Inc. devices

Submission Details

510(k) Number K792288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1979
Decision Date December 19, 1979
Days to Decision 36 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
66d faster than avg
Panel avg: 102d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSH Culture Media, Non-selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSH Culture Media, Non-selective And Differential

All 101
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K792288.
VOGEL-JOHNSON AGAR
K792542 · Isle Media and Sterile Products, Inc. · Dec 1979
LYSINE IRON AGAR
K792544 · Isle Media and Sterile Products, Inc. · Dec 1979
MR-VP MEDIUM
K792286 · Isle Media and Sterile Products, Inc. · Dec 1979
PHENOL RED AGAR
K791939 · Isle Media and Sterile Products, Inc. · Oct 1979
PHENOL RED BROTH
K791941 · Isle Media and Sterile Products, Inc. · Oct 1979
NITRATE AGAR
K791944 · Isle Media and Sterile Products, Inc. · Oct 1979