510(k) · Cleared
ClearedNeopip Patient Circuit with Peep
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoforce Group, Inc. · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on Apr 20, 2011 as substantially equivalent to K070416 (Neoforce Group, Inc., 2007) after a 111-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Apr 20, 2011
- Review
- 111 days
- Class
- Class II
- Product code
- BYE
- Recalls
- None
- 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.
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) | K103833 | Neopip Patient Circuit with Peep | Neoforce Group, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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.
Planning a device in BYE? 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? (3)
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 |
|---|---|---|---|
| * | K070416 | Neopeep Neonatal Resuscitation Circuit with PeepSummary page 1…21 CFR 868.5965 Attachment, Breathing, Positive End Expiratory Pressure, BYE, Class 11 Performance Standards: None applicable Predicate Device: K07041 6 NeoPEEP Neonatal Resuscitation Circuit with PEEP Device Description The NeoPPTM Resuscitation Circuit with PEEP… | 2007 |
| * | — | Fisher & Paykel NEOPUFF Infant Resuscitator patient circuit with PEEP Named without a submission number | |
| * | — | Marshall Products NeoPEEP NeoNatal Resuscitation Circuit with PEEP Named without a submission number |
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 22 years and passes through 2 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 devicesBYE Attachment, Breathing, Positive End Expiratory Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 NeoPIPTM Resuscitation Circuit with PEEP is indicated as an accessory to add positive end expiratory pressure breathing capability to a I-Piece Resuscitator. The PEEP valve is incorporated into the breathing circuit I-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The NeoPIP Resuscitation Circuit with PEEP is indicated for use in neonatal patients < 10Kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103833: Neopip Patient 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/K103833
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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