Cleared Traditional

K983002 - MYSTIQUE ULTRASONIC NEBULIZER

K983002 is an FDA 510(k) clearance for MYSTIQUE ULTRASONIC NEBULIZER, manufactured by Airsep Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K983002 · Airsep Corp. · Anesthesiology device
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Oct 1998
Decision
49d
Days
Class 2
Risk

K983002 is an FDA 510(k) clearance for the MYSTIQUE ULTRASONIC NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Airsep Corp. (Buffalo, US). The FDA issued a Cleared decision on October 16, 1998 after a review of 49 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. 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 Airsep Corp. devices

FDA 510(k) Submission Details - K983002

510(k) Number K983002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1998
Decision Date October 16, 1998
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
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 415
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K983002.
ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER
K983736 · Brasamerica Medical Equipment, Inc. · Nov 1998
BRENEB
K982043 · Bremed Italia, S.R.L. · Nov 1998
HALOLITE AAD SYSTEM
K981772 · Medic-Aid , Ltd. · Nov 1998
TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER
K982179 · Trudell Medical · Sep 1998
AEROTEE, MODEL # 1001
K982408 · Piper Medical Products · Sep 1998
BREATHERITE
K981944 · Ventlab Corp. · Aug 1998