Cleared Traditional

K894961 - MEDISONIC ULTRA-SONIC INHALER

K894961 is an FDA 510(k) clearance for MEDISONIC ULTRA-SONIC INHALER, manufactured by Medisonic U.S.A., Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K894961 · Medisonic U.S.A., Inc. · Anesthesiology device
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Nov 1989
Decision
109d
Days
Class 2
Risk

K894961 is an FDA 510(k) clearance for the MEDISONIC ULTRA-SONIC INHALER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medisonic U.S.A., Inc. (Clarence, US). The FDA issued a Cleared decision on November 24, 1989 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medisonic U.S.A., Inc. devices

FDA 510(k) Submission Details - K894961

510(k) Number K894961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1989
Decision Date November 24, 1989
Days to Decision 109 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 140d · This submission: 109d
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 396
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K894961.
H.E.A.R.T. NEBULIZER
K900228 · B&B Medical Technologies, Inc. · Mar 1990
INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT
K896923 · Intertech Resources, Inc. · Mar 1990
(HEART) NEBULIZER
K896696 · Vortran Medical Technology 1, Inc. · Feb 1990
CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
K895231 · Hudson Oxygen Therapy Sales Co. · Oct 1989
MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
K894138 · Medipart Jerry Alexander · Sep 1989
AEROCHAMBER M.V.
K884803 · Monaghan Medical Corp. · Apr 1989