Cleared Traditional

BIONOR TRANSPORTMEDIUM (K925450) - FDA 510(k) Clearance

Class I Microbiology device.

K925450 · Skoug Research Corp. · Microbiology device
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Jun 1993
Decision
240d
Days
Class 1
Risk

K925450 is an FDA 510(k) clearance for the BIONOR TRANSPORTMEDIUM. Classified as Culture Media, Anaerobic Transport (product code JSL), Class I - General Controls.

Submitted by Skoug Research Corp. (Cambridge, US). The FDA issued a Cleared decision on June 25, 1993 after a review of 240 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Skoug Research Corp. devices

Submission Details

510(k) Number K925450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1992
Decision Date June 25, 1993
Days to Decision 240 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 102d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSL Culture Media, Anaerobic Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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.