Cleared Special

K012006 - MEDICAL DEPOT POWER NEB 1

K012006 is an FDA 510(k) clearance for MEDICAL DEPOT POWER NEB 1, manufactured by Medical Depot, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 16-day FDA review.

K012006 · Medical Depot, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
16d
Days
Class 2
Risk

K012006 is an FDA 510(k) clearance for the MEDICAL DEPOT POWER NEB 1. 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 July 13, 2001 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K012006

510(k) Number K012006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2001
Decision Date July 13, 2001
Days to Decision 16 days
Submission Type Special
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
124d faster than avg
Panel avg: 140d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 K012006.
VORTEX VALVED HOLDING CHAMBER
K020944 · Pari Innovative Manufacturers, Inc. · May 2002
SALTER LABS MODIFIED NEBUTECH NEBULIZER
K014056 · Salter Labs · Feb 2002
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
K012939 · Monaghan Medical Corp. · Sep 2001
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
K012006 · MEDICAL DEPOT POWER NEB 1
Download PDF FDA Summary Medical Depot, Inc.