510(k) · Cleared

Cleared

Modification to: Sipap Infant Nasal Cpap Circuit

K012034510(k) SpecialCleared Jul 24, 200125-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

Sensor Medics Corp. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jul 24, 2001 as substantially equivalent to K960359 (Hamilton Medical, Inc., 1996) and 4 other predicates after a 25-day review. Its family tree reaches back 2 generations to 1995.

Decided: Jul 24, 2001
Review: 25 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 5

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 deviceK012034 Modification to: Sipap Infant Nasal Cpap CircuitSensor Medics Corp. · 2001

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)	K012034	Modification to: Sipap Infant Nasal Cpap Circuit	Sensor Medics Corp.	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1998	1	0
1999	1	0

FIG. 1 — Lineage of K012034, 1995–2001Source: 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? (5)

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
*	K960359	Aladdin Monitoring Oxygen/Air Mixer Summary page 1 …quivalency: The SiPAP Infant Nasal CPAP Circuit is the equivalent device circuit as the Infant Flow distributed by Hamilton Medical under the “Aladdin” name (510(k) #’s K960359 and K945740) and the Infant Fiow distributed by SensorMedics under 510(k)'s K974303, K984254 and K991972. Because there are no p…	Hamilton Medical, Inc.	1996	—
*	K945740	Infant Flow System Summary page 1 …The SiPAP Infant Nasal CPAP Circuit is the equivalent device circuit as the Infant Flow distributed by Hamilton Medical under the “Aladdin” name (510(k) #’s K960359 and K945740) and the Infant Fiow distributed by SensorMedics under 510(k)'s K974303, K984254 and K991972. Because there are no performance d…	Hamilton Medical, Inc.	1995	3
*	K974303	Infant Flow System Summary page 1 …the Infant Flow distributed by Hamilton Medical under the “Aladdin” name (510(k) #’s K960359 and K945740) and the Infant Fiow distributed by SensorMedics under 510(k)'s K974303, K984254 and K991972. Because there are no performance differences between the SensorMedics SiPAP Infant Nasal CPAP Circuit, the…	Sensor Medics Corp.	1998	—
*	K984254	Infant Flow Ncpap Masks Summary page 1 …nt Flow distributed by Hamilton Medical under the “Aladdin” name (510(k) #’s K960359 and K945740) and the Infant Fiow distributed by SensorMedics under 510(k)'s K974303, K984254 and K991972. Because there are no performance differences between the SensorMedics SiPAP Infant Nasal CPAP Circuit, the SensorMe…	Sensor Medics Corp.	1999	—
*	K991972	Infant Flow System Summary page 1 …ributed by Hamilton Medical under the “Aladdin” name (510(k) #’s K960359 and K945740) and the Infant Fiow distributed by SensorMedics under 510(k)'s K974303, K984254 and K991972. Because there are no performance differences between the SensorMedics SiPAP Infant Nasal CPAP Circuit, the SensorMedics Infant…	Sensor Medics Corp.	1999	—

Also cleared against K960359: 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 6 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
1 of the 6 ancestors has a recall of any class.
1 other device also cites its predicate K960359.

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 SensorMedics SiPAP Infant Nasal CPAP Circuit, consisting of a pressure generator, Nasal CPAP Prongs and Masks, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

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/K012034 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012034: Modification to: Sipap Infant Nasal Cpap Circuit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012034

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026