Cleared Traditional

K941627 - A&D UN-231 ULTRASONIC HANDY NEBULIZER

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

K941627 · A & D Corporate · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all A & D Corporate devices

FDA 510(k) Submission Details - K941627

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.

CAF Device Classification - Class 2, Special Controls

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 403
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K941627.
DUAL SPRAY MINISPACER
K955805 · Thayer Medical Corp. · Mar 1996
PULMOMIST
K952326 · Global Medical Ent., Inc. · Feb 1996
JET NEBULIZER
K952249 · Devilbiss Health Care, Inc. · Jan 1996
DEVILBISS MODEL 5500
K946095 · Devilbiss Health Care, Inc. · Aug 1995
3000 AEROSOL TWO
K943990 · Medical Industries America, Inc. · Mar 1995
AIRSEP NEWLIFE AIR OUTLET OPTION
K944020 · Airsep Corp. · Mar 1995