Cleared Special

K052941 - I-NEB INSIGHT AAD SYSTEM

K052941 is an FDA 510(k) clearance for I-NEB INSIGHT AAD SYSTEM, manufactured by Profile Therapeutics Plc. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 50-day FDA review.

K052941 · Profile Therapeutics Plc · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
50d
Days
Class 2
Risk

K052941 is an FDA 510(k) clearance for the I-NEB INSIGHT 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 December 9, 2005 after a review of 50 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 - K052941

510(k) Number K052941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2005
Decision Date December 09, 2005
Days to Decision 50 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
90d faster than avg
Panel avg: 140d · This submission: 50d
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 440
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K052941.
EMG HANDLE NEBULIZER NB02 SERIES
K052438 · Emg Technology Co., Ltd. · Jan 2006
HSINER JET NEBULIZER, MODEL HS-31100
K052811 · Hsiner Co., Ltd. · Dec 2005
MYNEB NEBULIZER, MODEL RDD100
K053203 · Respironics New Jersey, Inc. · Dec 2005
I-NEB AAD SYSTEM
K042991 · Profile Therapeutics Plc · Sep 2005
SCHUCO MIST AND SCHUCO DELUXE MIST
K051260 · Allied Healthcare Products, Inc. · Sep 2005
SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES
K050183 · Silvestrin Fabris S.R.L. · Aug 2005