Cleared Traditional

K852532 - NEWPORT MEDIA TRANSFER CONTAINER

K852532 is the FDA 510(k) clearance for NEWPORT MEDIA TRANSFER CONTAINER by Newport Bio Systems. It is a Class 1 Microbiology device (product code KJA) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K852532 · Newport Bio Systems · Microbiology device
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Aug 1985
Decision
69d
Days
Class 1
Risk

K852532 is an FDA 510(k) clearance for the NEWPORT MEDIA TRANSFER CONTAINER. Classified as Flask, Tissue Culture (product code KJA), Class I - General Controls.

Submitted by Newport Bio Systems (Santa Ana, US). The FDA issued a Cleared decision on August 22, 1985 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2240 - 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 Newport Bio Systems devices

Submission Details

510(k) Number K852532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date August 22, 1985
Days to Decision 69 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 102d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJA Flask, Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2240
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.