Cleared Traditional

K000543 - CONTEMPRO-MIST

K000543 is an FDA 510(k) clearance for CONTEMPRO-MIST, manufactured by Contemporary Products, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K000543 · Contemporary Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
119d
Days
Class 2
Risk

K000543 is an FDA 510(k) clearance for the CONTEMPRO-MIST. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Contemporary Products, Inc. (Portland, US). The FDA issued a Cleared decision on June 16, 2000 after a review of 119 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 - K000543

510(k) Number K000543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2000
Decision Date June 16, 2000
Days to Decision 119 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 140d · This submission: 119d
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 481
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K000543.
AERONEB PORTABLE NEBULIZER
K003022 · Aerogen, Inc. · Oct 2000
AERONEB II, MODEL APN 200
K992831 · Aerogen, Inc. · Aug 2000
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
K001137 · Trudell Medical Int'L · Jul 2000
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
K990435 · Apex Medical Corp. · Jun 2000
DEVILBISS NEBULIZER MODEL 800
K993492 · Sunrise Medical Hhg, Inc. · Apr 2000
POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER
K993199 · Ferraris Medical, Inc. · Mar 2000
K000543 · CONTEMPRO-MIST
Download PDF FDA Summary Contemporary Products…