Cleared Traditional

K791292 - BRAIN HEART INFUSION WITH AGAR BROTH

K791292 is the FDA 510(k) clearance for BRAIN HEART INFUSION WITH AGAR BROTH by Isle Media and Sterile Products, Inc.. It is a Class 1 Microbiology device (product code JSC) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K791292 · Isle Media and Sterile Products, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1979
Decision
22d
Days
Class 1
Risk

K791292 is an FDA 510(k) clearance for the BRAIN HEART INFUSION WITH AGAR BROTH. Classified as Culture Media, General Nutrient Broth (product code JSC), Class I - General Controls.

Submitted by Isle Media and Sterile Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 17, 1979 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2350 - 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 K791292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1979
Decision Date July 17, 1979
Days to Decision 22 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
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSC Culture Media, General Nutrient Broth
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2350
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 - JSC Culture Media, General Nutrient Broth

All 37
Devices cleared under the same product code (JSC) and FDA review panel - the closest regulatory comparables to K791292.
NUTRIENT BROTH
K791193 · Isle Media and Sterile Products, Inc. · Jul 1979
BRAIN HEART INFUSION BROTH
K791194 · Isle Media and Sterile Products, Inc. · Jul 1979
BRAIN HEART INFUSION WITH BROTH
K791291 · Isle Media and Sterile Products, Inc. · Jul 1979
BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2
K790687 · Gibco Laboratories Life Technologies, Inc. · May 1979
PEPTONE-YEAST EXTRACT BROTH
K790625 · Anaerobe Systems · May 1979
ENRICHED THIOGLYCOLLATE MEDIUM
K790616 · Anaerobe Systems · Apr 1979