510(k) · Cleared
ClearedModels 2R and 3R Pneupac Ventilator/Resuscitator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pneupac, Ltd. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Oct 15, 1986 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Oct 15, 1986
- Review
- 84 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK862830 Models 2R and 3R Pneupac Ventilator/ResuscitatorPneupac, Ltd. · 1986
- Descendant · cites it directly · 10 of its ownK024344 Pneuton VentilatorAiron Corporation · 2003
- Descendant · 2 generations on · 9 of its ownK043085 Modification to: Pneuton VentilatorAiron Corporation · 2004
- Descendant · 2 generations on · 7 of its ownK080692 Macs Cpap SystemAiron Corporation · 2008
- Descendant · 3 generations on · 4 of its ownK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
- Descendant · 4 generations on · 2 of its ownK102649 Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K024344Pneuton VentilatorAiron Corporation · 2003 · cites it directly10descendants
- K043085Modification to: Pneuton VentilatorAiron Corporation · 2004 · 2 generations on9descendants
- K080692Macs Cpap SystemAiron Corporation · 2008 · 2 generations on7descendants
- K092085Ispira Resuscitation UnitNeoforce Group, Inc. · 2009 · 3 generations on4descendants
- K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862830 | Models 2R and 3R Pneupac Ventilator/Resuscitator | Pneupac, Ltd. | 1986 | — |
| +1 | K024344 | Pneuton Ventilator | Airon Corporation | 2003 | — |
| +2 | K043085 | Modification to: Pneuton Ventilator | Airon Corporation | 2004 | — |
| +2 | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| +3 | K092085 | Ispira Resuscitation Unit | Neoforce Group, Inc. | 2009 | — |
| +4 | K102649 | Neopop Infant Resuscitator with Flow Meter | Neoforce Group, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTL? 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 BTL device
- #1 K242769 VentStar Resus heated (N) (MP17030); VentStar…score 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024344 | Pneuton Ventilator | 2003 | 10 |
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?
- Of its descendants, K024344 (Airon Corporation, 2003) has gone furthest, with 10 descendants of its own.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTL
203in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTL
2in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · BTL
165in 2025
MAUDE reports naming product code BTL, 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 | 5 | 122 | 1 | 5 |
| 2008 | 4 | 198 | 0 | 37 |
| 2009 | 5 | 173 | 0 | 69 |
| 2010 | 3 | 140 | 0 | 96 |
| 2011 | 2 | — | 1 | 75 |
| 2012 | 0 | — | 2 (2) | 115 |
| 2013 | 1 | — | 3 (1) | 103 |
| 2014 | 7 | 203 | 0 | 70 |
| 2015 | 1 | — | 3 (2) | 79 |
| 2016 | 0 | — | 0 | 80 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 1 | — | 0 | 197 |
| 2019 | 1 | — | 3 (3) | 341 |
| 2020 | 1 | — | 0 | 454 |
| 2021 | 1 | — | 1 | 506 |
| 2022 | 0 | — | 0 | 755 |
| 2023 | 1 | — | 0 | 731 |
| 2024 | 0 | — | 2 (2) | 667 |
| 2025 | 1 | — | 0 | 165 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K862830 · printed Nov 4, 2026
Cite this page
510(k) Report. “K862830: Models 2R and 3R Pneupac Ventilator/Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862830
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026