Cleared Traditional

K002543 - COMOACT ULTRASONIC NEBULIZER, MODEL 3060

K002543 is an FDA 510(k) clearance for COMOACT ULTRASONIC NEBULIZER, manufactured by San UP S.A.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K002543 · San UP S.A. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
302d
Days
Class 2
Risk

K002543 is an FDA 510(k) clearance for the COMOACT ULTRASONIC NEBULIZER, MODEL 3060. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by San UP S.A. (Great Neck, US). The FDA issued a Cleared decision on June 14, 2001 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 San UP S.A. devices

FDA 510(k) Submission Details - K002543

510(k) Number K002543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2000
Decision Date June 14, 2001
Days to Decision 302 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
162d slower than avg
Panel avg: 140d · This submission: 302d
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 334
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K002543.
800 SERIES EASYNEB NEBULIZER
K020357 · Nellcor Puritan Bennett, Inc. · Aug 2002
SALTER LABS MODIFIED NEBUTECH NEBULIZER
K014056 · Salter Labs · Feb 2002
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
K012939 · Monaghan Medical Corp. · Sep 2001
LITEAIRE
K993101 · Thayer Medical Corp. · Oct 2000
AERONEB II, MODEL APN 200
K992831 · Aerogen, Inc. · Aug 2000
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
K990435 · Apex Medical Corp. · Jun 2000