Cleared Special

K050104 - APEX MEDICAL MININEB & MINIPLUS

K050104 is an FDA 510(k) clearance for APEX MEDICAL MININEB & MINIPLUS, manufactured by Apex Medical Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 29-day FDA review.

K050104 · Apex Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
29d
Days
Class 2
Risk

K050104 is an FDA 510(k) clearance for the APEX MEDICAL MININEB & MINIPLUS. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Apex Medical Corp. (Tucheng City, Taipei County, TW). The FDA issued a Cleared decision on February 16, 2005 after a review of 29 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.

View all Apex Medical Corp. devices

FDA 510(k) Submission Details - K050104

510(k) Number K050104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date February 16, 2005
Days to Decision 29 days
Submission Type Special
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
111d faster than avg
Panel avg: 140d · This submission: 29d
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 223
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K050104.
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
INVACARE PRO, COMPACT AND PORTABLE DESKTOP
K042483 · Invacare Corporation · Jan 2005
NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
K041082 · Newport Medical Instruments, Inc. · Sep 2004
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
K041418 · Cardinalhealth · Jun 2004