Cleared Traditional

K941627 - A&D UN-231 ULTRASONIC HANDY NEBULIZER

K941627 is the FDA 510(k) clearance for A&D UN-231 ULTRASONIC HANDY NEBULIZER by A & D Corporate. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 633-day FDA review.

K941627 · A & D Corporate · Anesthesiology device
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Dec 1995
Decision
633d
Days
Class 2
Risk

K941627 is an FDA 510(k) clearance for the A&D UN-231 ULTRASONIC HANDY NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by A & D Corporate (Milpitas, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 633 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory 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: 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 Anesthesiology submissions.

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Submission Details

510(k) Number K941627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1994
Decision Date December 28, 1995
Days to Decision 633 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
493d slower than avg
Panel avg: 140d · This submission: 633d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 94
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K941627.
MODEL IRC 1199 SCOUT NEBULIZER
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MISTY OX TURBOHEATER
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K962161 · Baxter Healthcare Corp · Aug 1996
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K921809 · Puritan Bennett Corp. · Dec 1992
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K875134 · Nidek, Inc. · Dec 1988
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988