Cleared Traditional

K990435 - BESTNEB PORTABLE AEROSOL THERAPY UNIT

K990435 is an FDA 510(k) clearance for BESTNEB PORTABLE AEROSOL THERAPY UNIT, manufactured by Apex Medical Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 480-day FDA review.

K990435 · Apex Medical Corp. · Anesthesiology device
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Jun 2000
Decision
480d
Days
Class 2
Risk

K990435 is an FDA 510(k) clearance for the BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW). The FDA issued a Cleared decision on June 5, 2000 after a review of 480 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Apex Medical Corp. devices

FDA 510(k) Submission Details - K990435

510(k) Number K990435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1999
Decision Date June 05, 2000
Days to Decision 480 days
Submission Type Traditional
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
340d slower than avg
Panel avg: 140d · This submission: 480d
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 223
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K990435.
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
METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
K991355 · Instrumentation Industries, Inc. · Jan 2000
SALTER AIRE COMPRESSOR
K992285 · Salter Labs · Jan 2000
MODEL IRC 1001 AEROSOL COMPRESSOR
K992643 · Invacare Corp. · Oct 1999