Cleared Traditional

K990506 - MABIS NB-02 ULTRASONIC NEBULIZER

K990506 is an FDA 510(k) clearance for MABIS NB-02 ULTRASONIC NEBULIZER, manufactured by Mabis Healthcare, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K990506 · Mabis Healthcare, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
22d
Days
Class 2
Risk

K990506 is an FDA 510(k) clearance for the MABIS NB-02 ULTRASONIC NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Mabis Healthcare, Inc. (Lake Forest, US). The FDA issued a Cleared decision on March 11, 1999 after a review of 22 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 Mabis Healthcare, Inc. devices

FDA 510(k) Submission Details - K990506

510(k) Number K990506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1999
Decision Date March 11, 1999
Days to Decision 22 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
118d faster than avg
Panel avg: 140d · This submission: 22d
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 318
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K990506.
EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
K990384 · Piper Medical Products · Apr 1999
AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
K982722 · Ambu, Inc. · Apr 1999
MDILOG, MODEL MDC-512
K990185 · Medtrak Technologies, Inc. · Apr 1999
TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER
K982181 · Trudell Medical · Jan 1999
LS SERIES 200 FLOVISION SYSTEM
K971981 · Systam · Dec 1998
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
K983403 · Salter Labs · Dec 1998