Cleared Traditional

K884803 - AEROCHAMBER M.V.

K884803 is an FDA 510(k) clearance for AEROCHAMBER M.V., manufactured by Monaghan Medical Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K884803 · Monaghan Medical Corp. · Anesthesiology device
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Apr 1989
Decision
160d
Days
Class 2
Risk

K884803 is an FDA 510(k) clearance for the AEROCHAMBER M.V.. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on April 26, 1989 after a review of 160 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 Monaghan Medical Corp. devices

FDA 510(k) Submission Details - K884803

510(k) Number K884803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1988
Decision Date April 26, 1989
Days to Decision 160 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 140d · This submission: 160d
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 198
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K884803.
(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
HAND HELD NEBULIZER SYSTEM
K884947 · Salter Labs · Feb 1989
OMRON ULTRASONIC NEBULIZER NE-U06
K875134 · Nidek, Inc. · Dec 1988
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988