510(k) · Cleared
ClearedNeopop Infant Resuscitator with Flow Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoforce Group, Inc. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Jan 6, 2011 as substantially equivalent to K892885 (Fisher & Paykel Electronics, Ltd., 1989) and 2 other predicates after a 114-day review. Its family tree reaches back 5 generations to 1986. 2 later devices descend from it.
- Decided
- Jan 6, 2011
- Review
- 114 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K862830 (1986). 16 ancestors in all, the oldest K801883 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK862830 Models 2R and 3R Pneupac Ventilator/ResuscitatorPneupac, Ltd. · 1986
- 4 generations backK024344 Pneuton VentilatorAiron Corporation · 2003
- 3 generations backK043085 Modification to: Pneuton VentilatorAiron Corporation · 2004
- 2 generations backK080692 Macs Cpap SystemAiron Corporation · 2008
- 1 generation backK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
- This deviceK102649 Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK110119 Pressure ManometerNeoforce Group, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK122627 Gio Digital Pressure GuagesGalemed Corp. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862830 | Models 2R and 3R Pneupac Ventilator/Resuscitator | Pneupac, Ltd. | 1986 | — |
| −4 | K024344 | Pneuton Ventilator | Airon Corporation | 2003 | — |
| −3 | K043085 | Modification to: Pneuton Ventilator | Airon Corporation | 2004 | — |
| −2 | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| −1 | K092085 | Ispira Resuscitation Unit | Neoforce Group, Inc. | 2009 | — |
| 0 (this device) | K102649 | Neopop Infant Resuscitator with Flow Meter | Neoforce Group, Inc. | 2011 | — |
| +1 | K110119 | Pressure Manometer | Neoforce Group, Inc. | 2011 | — |
| +2 | K122627 | Gio Digital Pressure Guages | Galemed Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 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 BTM? 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 BTM device
- #1 K243861 butterflyBVMscore 9.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K892885 | Resubmitted RD1000 Neopuff Infant ResuscitatorSummary page 1…Anesthesiology 21 CFR 868.5915 Manual Emergency Ventilator, BTM, Class 11 Performance Standards: None applicable Predicate Device: K892885 Fisher & Paykel, Neopuff Infant Resuscitator K072021 NeoPIP Infant Resuscitation Unit K092085 Ispira Resusciation S… | 1989 |
| * | K072021 | Neopip Infant ResuscitatorSummary page 1…mergency Ventilator, BTM, Class 11 Performance Standards: None applicable Predicate Device: K892885 Fisher & Paykel, Neopuff Infant Resuscitator K072021 NeoPIP Infant Resuscitation Unit K092085 Ispira Resusciation System Device Description The NeoPIP Infant Resuscitator wi… | 2007 |
| * | K092085 | Ispira Resuscitation UnitSummary page 1…Standards: None applicable Predicate Device: K892885 Fisher & Paykel, Neopuff Infant Resuscitator K072021 NeoPIP Infant Resuscitation Unit K092085 Ispira Resusciation System Device Description The NeoPIP Infant Resuscitator with Flow Meter is intended to deliver oxygen or b… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110119 | Pressure Manometer | 2011 | 1 |
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 25 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K110119 (Neoforce Group, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K892885.
How does its category compare?
All BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BTM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTM
83in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTM
9in 2024
Class I (24 since 2007) Class II/III not classified
Adverse event reports per year · BTM
36in 2025
MAUDE reports naming product code BTM, 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 | 2 | — | 0 | 65 |
| 2008 | 3 | 83 | 0 | 31 |
| 2009 | 0 | — | 23 | 21 |
| 2010 | 2 | — | 3 | 23 |
| 2011 | 2 | — | 0 | 48 |
| 2012 | 1 | — | 13 (13) | 69 |
| 2013 | 0 | — | 3 (1) | 44 |
| 2014 | 0 | — | 0 | 108 |
| 2015 | 1 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 92 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 2 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 46 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 9 | 46 |
| 2024 | 0 | — | 9 (9) | 33 |
| 2025 | 2 | — | 0 | 36 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The NeoPIP Infant Resuscitator with Flow Meter is a manually operated, gas powered device with integrated flow meter intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102649: Neopop Infant Resuscitator with Flow Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102649
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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