Cleared Special

K983736 - ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER

K983736 is an FDA 510(k) clearance for ICEL EVOLUSONIC PORTABLE ULTRASONIC NEB..., manufactured by Brasamerica Medical Equipment, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 19-day FDA review.

K983736 · Brasamerica Medical Equipment, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
19d
Days
Class 2
Risk

K983736 is an FDA 510(k) clearance for the ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Brasamerica Medical Equipment, Inc. (Great Neck,, US). The FDA issued a Cleared decision on November 10, 1998 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Brasamerica Medical Equipment, Inc. devices

FDA 510(k) Submission Details - K983736

510(k) Number K983736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1998
Decision Date November 10, 1998
Days to Decision 19 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 248
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METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D
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BREATHERITE
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