510(k) · Cleared
Cleared0-20 CM H20 Peep Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cheen Houng Ent. Co., Ltd. · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on Jul 14, 1998 after an 85-day review. The FDA summary names its predicate without a number. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jul 14, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- BYE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK981415 0-20 CM H20 Peep ValveCheen Houng Ent. Co., Ltd. · 1998
- Descendant · cites it directly · 2 of its ownK070416 Neopeep Neonatal Resuscitation Circuit with PeepNeoforce Group, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK103833 Neopip Patient Circuit with PeepNeoforce Group, Inc. · 2011
- Descendant · 2 generations on · 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…2 generations on · 2010
Most influential descendants
Showing 3 of 3 · See all- K070416Neopeep Neonatal Resuscitation Circuit with PeepNeoforce Group, Inc. · 2007 · cites it directly2descendants
- K103833Neopip Patient Circuit with PeepNeoforce Group, Inc. · 2011 · 2 generations on0descendants
- K092029Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310Draeger Medical AG & Co. KG · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981415 | 0-20 CM H20 Peep Valve | Cheen Houng Ent. Co., Ltd. | 1998 | — |
| +1 | K070416 | Neopeep Neonatal Resuscitation Circuit with Peep | Neoforce Group, Inc. | 2007 | — |
| +2 | K103833 | Neopip Patient Circuit with Peep | Neoforce Group, Inc. | 2011 | — |
| +2 | K092029 | Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310 | Draeger Medical AG & Co. KG | 2010 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 1 |
| 2011 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | — | Life Design PEEP FLO PEEP Valves Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070416 | Neopeep Neonatal Resuscitation Circuit with Peep | 2007 | 2 |
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 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K070416 (Neoforce Group, Inc., 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All BYE devicesBYE Attachment, Breathing, Positive End Expiratory Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BYE
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · BYE
117in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYE
1in 2015
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BYE
7in 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 Cheen Houng 0-20 Cm H20 PEEP Valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator.
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/K981415 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981415: 0-20 CM H20 Peep Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981415
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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