Cleared Traditional

ARABELLA NCPAP MASKS (K030563) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030563 · Hamilton Medical AG · Anesthesiology device
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Sep 2003
Decision
200d
Days
Class 2
Risk

K030563 is an FDA 510(k) clearance for the ARABELLA NCPAP MASKS. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Hamilton Medical AG (Reno, US). The FDA issued a Cleared decision on September 9, 2003 after a review of 200 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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. Standard predicate reliance. 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 Hamilton Medical AG devices

Submission Details

510(k) Number K030563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2003
Decision Date September 09, 2003
Days to Decision 200 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
60d slower than avg
Panel avg: 140d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K030563.
MIRAGE ACTIVA MASK
K032916 · Resmed, Ltd. · Dec 2003
NASAL JACKS MASK
K032433 · Resmed, Ltd. · Oct 2003
AUTOSET SPIRIT SYSTEM
K032480 · Resmed, Ltd. · Oct 2003
MIRAGE VISTA MASK
K031047 · Resmed, Ltd. · Aug 2003
VPAP III
K030843 · Resmed, Ltd. · Aug 2003
S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
K024191 · Resmed, Ltd. · Jul 2003