510(k) · Cleared

Recalled · Class II · 2015

Infant Flow System

K945740510(k) TraditionalCleared Mar 23, 1995120-day reviewClass I21 CFR 868.5975Recalls 3

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

Hamilton Medical, Inc. · BZO Set, Tubing And Support, Ventilator (W Harness)

Cleared on Mar 23, 1995 after a 120-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled 3 times.

Decided: Mar 23, 1995
Review: 120 days
Class: Class I
Product code: BZO
Recalls: 3
Predicates: 0

3 later devices descend from it, 2 citing it directly.

This deviceK945740 Infant Flow SystemHamilton Medical, Inc. · 1995
Descendant · cites it directly · 2 of its ownK984254 Infant Flow Ncpap MasksSensor Medics Corp. · 1999
Descendant · 2 generations on · 0 of its ownK030563 Arabella Ncpap MasksHamilton Medical AG · 2003
Descendant · cites it directly · 0 of its ownK012034 Modification to: Sipap Infant Nasal Cpap CircuitSensor Medics Corp. · 2001

Most influential descendants

Showing 3 of 3 · See all

K984254Infant Flow Ncpap MasksSensor Medics Corp. · 1999 · cites it directly2descendants
K030563Arabella Ncpap MasksHamilton Medical AG · 2003 · 2 generations on0descendants
K012034Modification to: Sipap Infant Nasal Cpap CircuitSensor Medics Corp. · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K945740	Infant Flow System	Hamilton Medical, Inc.	1995	—
+1	K984254	Infant Flow Ncpap Masks	Sensor Medics Corp.	1999	—
+2	K030563	Arabella Ncpap Masks	Hamilton Medical AG	2003	—
+1	K012034	Modification to: Sipap Infant Nasal Cpap Circuit	Sensor Medics Corp.	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2003	1	0

FIG. 1 — Lineage of K945740, 1995–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K984254	Infant Flow Ncpap Masks	Sensor Medics Corp.	1999	2
K012034	Modification to: Sipap Infant Nasal Cpap Circuit	Sensor Medics Corp.	2001	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 1, 2015	Class II	Z-1964-2015	Device Design	An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow…
Jun 1, 2015	Class II	Z-1963-2015	Device Design	An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow…
Jun 1, 2015	Class II	Z-1965-2015	Device Design	An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K984254 (Sensor Medics Corp., 1999) has gone furthest, with 2 descendants of its own.

How does its category compare?

All BZO devices

BZO Set, Tubing And Support, Ventilator (W Harness): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZO

FDA has decided no BZO device since 2007.

Median 510(k) review, days · BZO

Too few BZO 510(k)s in any year since 2007 to give a median.

Recalls per year · BZO

2so far in 2026, the most since 2007

2007high 2 (2026) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · BZO

70in 2025

2007high 186 (2011) · low 26 (2018)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	43
2008	—	0	41
2009	—	0	46
2010	—	0	140
2011	—	0	186
2012	—	1 (1)	99
2013	—	0	122
2014	—	0	84
2015	—	0	55
2016	—	0	56
2017	—	0	46
2018	—	0	26
2019	—	0	33
2020	—	0	30
2021	—	0	52
2022	—	0	66
2023	—	0	37
2024	—	0	45
2025	—	1 (1)	70
2026	—	2 (1)	—

https://510kreport.com/device/K945740 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945740: Infant Flow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945740

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026