Cleared Traditional

K820863 - MEDIA FOR IN-VITRO DIAGNOSTIC USE

K820863 is the FDA 510(k) clearance for MEDIA FOR IN-VITRO DIAGNOSTIC USE by Isle Media and Sterile Products, Inc.. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K820863 · Isle Media and Sterile Products, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
18d
Days
Class 1
Risk

K820863 is an FDA 510(k) clearance for the MEDIA FOR IN-VITRO DIAGNOSTIC USE. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Isle Media and Sterile Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1982 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 K820863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1982
Decision Date April 16, 1982
Days to Decision 18 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
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 239
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K820863.
MYCOBIOTIC AGAR
K821603 · Hardy Media · Jul 1982
LITTMAN OXGAL AGAR
K821493 · Granite Diagnostics, Inc. · Jun 1982
CAMPY-S AGAR
K821218 · Isle Media and Sterile Products, Inc. · May 1982
POTATO DEXTROSE AGAR
K820550 · American Laboratory Supply, Inc. · Mar 1982
DERMATHPHYTE TEST MEDIUM
K820557 · American Laboratory Supply, Inc. · Mar 1982
PHENYLETHANOL AGAR W/5% SHEEP BLOOD
K820560 · American Laboratory Supply, Inc. · Mar 1982