Cleared Abbreviated

K052438 - EMG HANDLE NEBULIZER NB02 SERIES

K052438 is an FDA 510(k) clearance for EMG HANDLE NEBULIZER NB02 SERIES, manufactured by Emg Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Abbreviated 510(k) pathway after a 147-day FDA review.

K052438 · Emg Technology Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
147d
Days
Class 2
Risk

K052438 is an FDA 510(k) clearance for the EMG HANDLE NEBULIZER NB02 SERIES. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Emg Technology Co., Ltd. (Wilkes Barre, US). The FDA issued a Cleared decision on January 31, 2006 after a review of 147 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K052438

510(k) Number K052438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2005
Decision Date January 31, 2006
Days to Decision 147 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 140d · This submission: 147d
Pathway characteristics
Standards-based clearance path.

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 K052438.
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
K053360 · Aerovectrx Corporation · Mar 2006
LC SPRINT NEBULIZER
K060399 · Pari Innovative Manufacturers, Inc. · Mar 2006
AEROECLIPSE II BREATH ACTUATED NEBULIZER
K053605 · Trudell Medical Intl. · Feb 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 INSIGHT AAD SYSTEM
K052941 · Profile Therapeutics Plc · Dec 2005