510(k) · Cleared

Cleared

Arabella Ncpap Masks

K030563510(k) TraditionalCleared Sep 9, 2003200-day reviewClass II21 CFR 868.5905

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hamilton Medical AG · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Sep 9, 2003 as substantially equivalent to K984254 (Sensor Medics Corp., 1999) and 1 other predicate after a 200-day review. Its family tree reaches back 2 generations to 1995.

Decided: Sep 9, 2003
Review: 200 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K945740 (1995). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK945740 Infant Flow SystemHamilton Medical, Inc. · 1995 · Recalled
1 generation backK984254 Infant Flow Ncpap MasksSensor Medics Corp. · 1999
This deviceK030563 Arabella Ncpap MasksHamilton Medical AG · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K945740	Infant Flow System	Hamilton Medical, Inc.	1995	3
−1	K984254	Infant Flow Ncpap Masks	Sensor Medics Corp.	1999	—
0 (this device)	K030563	Arabella Ncpap Masks	Hamilton Medical AG	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1998	1	0
2001	1	0

FIG. 1 — Lineage of K030563, 1995–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new BZD device

#1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K984254	Infant Flow Ncpap Masks Summary page 2 …l testing laboratory. 9. Substantial Equivalence: The Hamilton ARABELLA@ NCPAP Masks are substantially equivalent to the SensorMedicdEME Infant Flow Nasal CPAP Mask (K984254/K0 1 I5 16). Among the information and data presented in the 510(k) submission to support the equivalency of the ARABELLA@…	Sensor Medics Corp.	1999	—
*	K011516	Infant Flow System, Model M672P Summary page 2 …that follows describes the important characteristics of the ARABELLA@NCPAP Masks and its predicate device: SensorMedics/EME Infant Flow Nasal CPAP Mask (K984254/K0115 16). 2 # \| Characteristic \| SensorMedics/EME Infant Flow Nasal CP…	Eme (Electro Medical Equipment), Ltd.	2001	—

Also cleared against K984254: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
1 of the 6 ancestors has a recall of any class.
1 other device also cites its predicate K984254.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZD

7in 2025

2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007high 280 (2018) · low 83 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZD

8in 2023

2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	21	83	29	65
2008	17	108	2	67
2009	23	90	1	147
2010	12	122	0	143
2011	23	125	1	189
2012	21	133	0	139
2013	23	127	0	82
2014	14	172	0	86
2015	11	224	0	114
2016	12	217	0	118
2017	5	221	0	148
2018	5	280	0	101
2019	6	231	4 (4)	188
2020	6	137	0	126
2021	6	192	0	6,066
2022	4	253	0	90,768
2023	5	204	8 (7)	27,987
2024	10	132	0	68,262
2025	7	189	0	60,279
2026	10	214	2 (2)	—

What is it indicated for?

The Hamilton Medical ARABELLA’ NCPAP Masks (single patient use only) are intended for use with the Hamilton ARABELLA’ infant nasal CPAP system which consists of (a.) the tubing and support set and (b.) the monitoring oxygen/air mixer, This system is intended to provide CPAP therapy with a nasal mask or nasal prongs in hospitals or other clinical settings to treat newborns and infants.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K030563 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030563: Arabella Ncpap Masks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030563

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026