510(k) · Cleared

Recalled · Class I · 2026

Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310

K092029510(k) TraditionalCleared Aug 6, 2010396-day reviewClass II21 CFR 868.5965Recalls 1 (1 Class I)

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

Draeger Medical AG & Co. KG · BYE Attachment, Breathing, Positive End Expiratory Pressure

Cleared on Aug 6, 2010 as substantially equivalent to K070416 (Neoforce Group, Inc., 2007) after a 396-day review. Its family tree reaches back 2 generations to 1989. 1 of the 4 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided: Aug 6, 2010
Review: 396 days
Class: Class II
Product code: BYE
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 2 generations to K892885 (1989). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK892885 Resubmitted RD1000 Neopuff Infant ResuscitatorFisher & Paykel Electronics, Ltd. · 1989
1 generation backK070416 Neopeep Neonatal Resuscitation Circuit with PeepNeoforce Group, Inc. · 2007
This deviceK092029 Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu…Draeger Medical AG & Co. KG · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K892885	Resubmitted RD1000 Neopuff Infant Resuscitator	Fisher & Paykel Electronics, Ltd.	1989	—
−1	K070416	Neopeep Neonatal Resuscitation Circuit with Peep	Neoforce Group, Inc.	2007	—
0 (this device)	K092029	Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310	Draeger Medical AG & Co. KG	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K092029, 1989–2010Source: 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.

1 device in this family has a Class I recall. 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K070416	Neopeep Neonatal Resuscitation Circuit with Peep Summary page 2 …er and Siemens Company Legally Marketed Device to which Substantial Equivalence is claimed: 510(k) number ”: .’. Tl’a‘del"la.!l‘le.' ".', * 3 IR '.a b e Company KO070416 Device Description: NeoPeep Neoforce Group; Ihc. The VentStar Resuscitaire CEU with PEEP valve is indicated as accessory to a…	Neoforce Group, Inc.	2007	—

Also cleared against K070416: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 3, 2026	Class I	Z-3252-2026	Under Investigation by firm	Potential cracks in the hose, which could lead to leakage or the hose falling off.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 17.6 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K070416.

How does its category compare?

All BYE devices

BYE Attachment, Breathing, Positive End Expiratory Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · BYE

1in 2016

2007high 3 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BYE

117in 2011

2007high 155 (2009) · low 117 (2011)2026

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

Recalls per year · BYE

1in 2015

2007high 4 (2007) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BYE

7in 2025

2007high 11 (2018) · low 0 (2016)2025

MAUDE reports naming product code BYE, 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	1	—	4	8
2008	1	—	2	3
2009	3	155	0	1
2010	1	—	0	4
2011	3	117	0	2
2012	0	—	0	6
2013	1	—	0	2
2014	2	—	0	8
2015	0	—	1	4
2016	1	—	0	0
2017	0	—	0	3
2018	0	—	0	11
2019	0	—	0	5
2020	0	—	0	5
2021	0	—	0	4
2022	0	—	0	10
2023	0	—	0	8
2024	0	—	0	9
2025	0	—	0	7
2026	0	—	1 (1)	—

What is it indicated for?

The VentStar Resuscitaire CEU with PEEP valve is indicated as an accessory to add

positive end expiratory pressure breathing capability. The valve is designed into the

breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or

endotracheal tube.

The VentStar Resuscitaire CEU is a disposable breathing circuit for the transmission of

breathing gases from a breathing gas source (Resuscitation Module) to the newborn patient

in labor and delivery environments. It is suitable for newborn patients from birth to 1 month

of age (maximum body weight of 10 kg (22 Ib)). It is intended exclusively for use in

combination with the Resuscitaire Radiant Warmer.

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/K092029 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092029: Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092029

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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