Cleared Traditional

K982181 - TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER

K982181 is an FDA 510(k) clearance for TRUMIST BREATH ACTUATED DISPOSABLE NEBU..., manufactured by Trudell Medical. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K982181 · Trudell Medical · Anesthesiology device
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Jan 1999
Decision
200d
Days
Class 2
Risk

K982181 is an FDA 510(k) clearance for the TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Trudell Medical (London, CA). The FDA issued a Cleared decision on January 8, 1999 after a review of 200 days - an extended review 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: 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 Trudell Medical devices

FDA 510(k) Submission Details - K982181

510(k) Number K982181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1998
Decision Date January 08, 1999
Days to Decision 200 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
60d slower than avg
Panel avg: 140d · This submission: 200d
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 K982181.
AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
K982722 · Ambu, Inc. · Apr 1999
MDILOG, MODEL MDC-512
K990185 · Medtrak Technologies, Inc. · Apr 1999
MABIS NB-02 ULTRASONIC NEBULIZER
K990506 · Mabis Healthcare, Inc. · Mar 1999
LS SERIES 200 FLOVISION SYSTEM
K971981 · Systam · Dec 1998
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
K983403 · Salter Labs · Dec 1998
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D
K981249 · Instrumentation Industries, Inc. · Nov 1998