Cleared Traditional

A549 CELL CULTURE (K955921) - FDA 510(k) Clearance

Class I Microbiology device.

K955921 · Viratest Intl., Inc. · Microbiology device
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Feb 1996
Decision
64d
Days
Class 1
Risk

K955921 is an FDA 510(k) clearance for the A549 CELL CULTURE. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Viratest Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on February 16, 1996 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2280 - 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 Viratest Intl., Inc. devices

Submission Details

510(k) Number K955921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1995
Decision Date February 16, 1996
Days to Decision 64 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
38d faster than avg
Panel avg: 102d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIR Cells, Animal And Human, Cultured
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2280
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.