Cleared Traditional

K030563 - ARABELLA NCPAP MASKS

K030563 is an FDA 510(k) clearance for ARABELLA NCPAP MASKS, manufactured by Hamilton Medical AG. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 200-day FDA review.

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

FDA 510(k) Submission Details - K030563

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
Combination Product No
PCCP Authorized No
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.

BZD Device Classification - Class 2, Special Controls

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 306
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K030563.
NASAL JACKS MASK
K032433 · Resmed, Ltd. · Oct 2003
AUTOSET SPIRIT SYSTEM
K032480 · Resmed, Ltd. · Oct 2003
BREAS PV 10I CPAP SYSTEM, MODEL PV 10I
K030985 · Vital Signs, Inc. · Oct 2003
LYRA NASAL MASK
K031883 · Sensor Medics Corp. · Aug 2003
MIRAGE VISTA MASK
K031047 · Resmed, Ltd. · Aug 2003
VPAP III
K030843 · Resmed, Ltd. · Aug 2003