Cleared Traditional

K843717 - VIRATEK SMALL PARTICLE AEROSOL GENERAT (FDA 510(k) Clearance)

K843717 · Viratek, Inc. · Cardiovascular device
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Dec 1985
Decision
465d
Days
-
Risk

K843717 is an FDA 510(k) clearance for the VIRATEK SMALL PARTICLE AEROSOL GENERAT.

Submitted by Viratek, Inc. (Walker, US). The FDA issued a Cleared decision on December 30, 1985 after a review of 465 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Viratek, Inc. devices

Submission Details

510(k) Number K843717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1984
Decision Date December 30, 1985
Days to Decision 465 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
340d slower than avg
Panel avg: 125d · This submission: 465d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -