Cleared Traditional

TRANSETTE SYSTEM/COLLECTION & TRANSP (K802563) - FDA 510(k) Clearance

Class I Microbiology device.

K802563 · Inolex Corp./Div of Biomedical · Microbiology device
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Oct 1980
Decision
15d
Days
Class 1
Risk

K802563 is an FDA 510(k) clearance for the TRANSETTE SYSTEM/COLLECTION & TRANSP. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Inolex Corp./Div of Biomedical (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Inolex Corp./Div of Biomedical devices

Submission Details

510(k) Number K802563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1980
Decision Date October 31, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - JTW System, Transport, Aerobic

Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K802563.
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