Cleared Traditional

K042991 - I-NEB AAD SYSTEM

K042991 is an FDA 510(k) clearance for I-NEB AAD SYSTEM, manufactured by Profile Therapeutics Plc. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K042991 · Profile Therapeutics Plc · Anesthesiology device
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Sep 2005
Decision
326d
Days
Class 2
Risk

K042991 is an FDA 510(k) clearance for the I-NEB AAD SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Profile Therapeutics Plc (Murrysville, US). The FDA issued a Cleared decision on September 23, 2005 after a review of 326 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 Profile Therapeutics Plc devices

FDA 510(k) Submission Details - K042991

510(k) Number K042991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date September 23, 2005
Days to Decision 326 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
186d slower than avg
Panel avg: 140d · This submission: 326d
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 224
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K042991.
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
K062263 · Omron Healthcare, Inc. · Feb 2007
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
K053490 · Merits Health Products Co., Ltd. · Jul 2006
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
K060811 · Omron Healthcare, Inc. · May 2006
SCHUCO MIST AND SCHUCO DELUXE MIST
K051260 · Allied Healthcare Products, Inc. · Sep 2005
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
K051365 · K-Jump Health Co., Ltd. · Jul 2005
APEX MEDICAL MININEB & MINIPLUS
K050104 · Apex Medical Corp. · Feb 2005