510(k) · Cleared

Cleared

Neopeep Neonatal Resuscitation Circuit with Peep

K070416510(k) TraditionalCleared May 29, 2007106-day reviewClass II21 CFR 868.5965

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

Neoforce Group, Inc. · BYE Attachment, Breathing, Positive End Expiratory Pressure

Cleared on May 29, 2007 as substantially equivalent to K892885 (Fisher & Paykel Electronics, Ltd., 1989) and 1 other predicate after a 106-day review. Its family tree reaches back 1 generation to 1989. 1 of the 5 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: May 29, 2007
Review: 106 days
Class: Class II
Product code: BYE
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K892885 (1989). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK892885 Resubmitted RD1000 Neopuff Infant ResuscitatorFisher & Paykel Electronics, Ltd. · 1989
This deviceK070416 Neopeep Neonatal Resuscitation Circuit with PeepNeoforce Group, Inc. · 2007
Descendant · cites it directly · 0 of its ownK103833 Neopip Patient Circuit with PeepNeoforce Group, Inc. · 2011
Descendant · cites it directly · 0 of its ownK092029 Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu…Draeger Medical AG & Co. KG · 2010 · Recalled (Class I)

Class I recalls in this family

K092029 Ventstar Resuscitaire, Model MP00311, Ventstar…cites it directly · 2010

Most influential descendants

Showing 2 of 2 · See all

K103833Neopip Patient Circuit with PeepNeoforce Group, Inc. · 2011 · cites it directly0descendants
K092029Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310Draeger Medical AG & Co. KG · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K892885	Resubmitted RD1000 Neopuff Infant Resuscitator	Fisher & Paykel Electronics, Ltd.	1989	—
0 (this device)	K070416	Neopeep Neonatal Resuscitation Circuit with Peep	Neoforce Group, Inc.	2007	—
+1	K103833	Neopip Patient Circuit with Peep	Neoforce Group, Inc.	2011	—
+1	K092029	Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310	Draeger Medical AG & Co. KG	2010	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	1
2011	1	0

FIG. 1 — Lineage of K070416, 1989–2011Source: 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

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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
*	K892885	Resubmitted RD1000 Neopuff Infant Resuscitator Summary page 1 …CFR 868.5965 Attachment, Breathing, Positive End Expiratory Pressure, BYE, Class II Performance Standards: None applicable Predicate Device: K892885 NEOPUFF Infant Resuscitator K981415 0-20 cm H20 PEEP Valve Device Description P…	Fisher & Paykel Electronics, Ltd.	1989	—
*	K981415	0-20 CM H20 Peep Valve Summary page 1 …Positive End Expiratory Pressure, BYE, Class II Performance Standards: None applicable Predicate Device: K892885 NEOPUFF Infant Resuscitator K981415 0-20 cm H20 PEEP Valve Device Description Page 31 of 32 The NeoPEEP Neo…	Cheen Houng Ent. Co., Ltd.	1998	—

Also cleared against K892885: 11 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K103833	Neopip Patient Circuit with Peep	Neoforce Group, Inc.	2011	0
K092029	Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310 Class I	Draeger Medical AG & Co. KG	2010	0

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

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K092029Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310Draeger Medical AG & Co. KG · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K103833 (Neoforce Group, Inc., 2011) has gone furthest, with 0 descendants of its own.
11 other devices also cite its predicate K892885.

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. 2007, 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 NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator. This valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube attachment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070416 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070416: Neopeep Neonatal Resuscitation Circuit with Peep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070416

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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