Cleared Traditional

K851695 - ULTRA-NEB 100 ULTRASONIC NEBULIZER (FDA 510(k) Clearance)

K851695 · The Devilbiss Co. · Cardiovascular device
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Jun 1985
Decision
44d
Days
-
Risk

K851695 is an FDA 510(k) clearance for the ULTRA-NEB 100 ULTRASONIC NEBULIZER.

Submitted by The Devilbiss Co. (Somerset, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 44 days - a notably fast clearance cycle.

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: 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 The Devilbiss Co. devices

Submission Details

510(k) Number K851695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1985
Decision Date June 05, 1985
Days to Decision 44 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -