Cleared Traditional

K003344 - MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2

K003344 is an FDA 510(k) clearance for MEDICAL DEPOT NEBULIZER, manufactured by Medical Depot, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K003344 · Medical Depot, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
141d
Days
Class 2
Risk

K003344 is an FDA 510(k) clearance for the MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medical Depot, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on March 15, 2001 after a review of 141 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K003344

510(k) Number K003344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2000
Decision Date March 15, 2001
Days to Decision 141 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 140d · This submission: 141d
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 507
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K003344.
COMOACT ULTRASONIC NEBULIZER, MODEL 3060
K002543 · San UP S.A. · Jun 2001
VEGA ULTRASONIC NEBULIZER
K002831 · Vega Technologies, Inc. · May 2001
CT SPACER
K010680 · Clinical Technologies, Inc. · May 2001
ULTRASONIC NEBULIZER, MODEL NE-520
K002153 · Medisana USA, Inc. · Mar 2001
LITEAIRE
K993101 · Thayer Medical Corp. · Oct 2000
AERONEB PORTABLE NEBULIZER
K003022 · Aerogen, Inc. · Oct 2000
K003344 · MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
Download PDF FDA Summary Medical Depot, Inc.