Cleared Traditional

K791631 - SABOURAUD DEXTROSE AGAR

K791631 is the FDA 510(k) clearance for SABOURAUD DEXTROSE AGAR by Isle Media and Sterile Products, Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K791631 · Isle Media and Sterile Products, Inc. · Microbiology device
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Sep 1979
Decision
37d
Days
Class 1
Risk

K791631 is an FDA 510(k) clearance for the SABOURAUD DEXTROSE AGAR. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Isle Media and Sterile Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 37 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 Isle Media and Sterile Products, Inc. devices

Submission Details

510(k) Number K791631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1979
Decision Date September 27, 1979
Days to Decision 37 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
65d faster than avg
Panel avg: 102d · This submission: 37d
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 K791631.
CDC ANAEROBIC SHEEP BLOOD AGAR (BA)
K791698 · Gibco Laboratories Life Technologies, Inc. · Oct 1979
BRAIN HEART INFUSION AGAR 5% SHEEP BLOOD
K791628 · Isle Media and Sterile Products, Inc. · Sep 1979
BRAIN HEART INFUSION AGAR
K791630 · Isle Media and Sterile Products, Inc. · Sep 1979
TRYPTIC SOY AGAR 5% SHEEP BLOOD
K791620 · American Laboratory Supply, Inc. · Sep 1979
COLUMBIA AGAR WITH5% SHEEP
K791622 · American Laboratory Supply, Inc. · Sep 1979
THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR
K791542 · Isle Media and Sterile Products, Inc. · Sep 1979