510(k) · Cleared
ClearedModification to: Pneuton Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airon Corporation · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 20, 2004 as substantially equivalent to K024344 (Airon Corporation, 2003) and 1 other predicate after a 42-day review. Its family tree reaches back 2 generations to 1986. 9 later devices descend from it.
- Decided
- Dec 20, 2004
- Review
- 42 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K862830 (1986). 4 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK862830 Models 2R and 3R Pneupac Ventilator/ResuscitatorPneupac, Ltd. · 1986
- 1 generation backK024344 Pneuton VentilatorAiron Corporation · 2003
- This deviceK043085 Modification to: Pneuton VentilatorAiron Corporation · 2004
- Descendant · cites it directly · 7 of its ownK080692 Macs Cpap SystemAiron Corporation · 2008
- Descendant · 2 generations on · 4 of its ownK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
- Descendant · 3 generations on · 2 of its ownK102649 Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK110119 Pressure ManometerNeoforce Group, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK093862 Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K080692Macs Cpap SystemAiron Corporation · 2008 · cites it directly7descendants
- K092085Ispira Resuscitation UnitNeoforce Group, Inc. · 2009 · 2 generations on4descendants
- K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011 · 3 generations on2descendants
- K110119Pressure ManometerNeoforce Group, Inc. · 2011 · 3 generations on1descendant
- K093862Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 2010 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862830 | Models 2R and 3R Pneupac Ventilator/Resuscitator | Pneupac, Ltd. | 1986 | — |
| −1 | K024344 | Pneuton Ventilator | Airon Corporation | 2003 | — |
| 0 (this device) | K043085 | Modification to: Pneuton Ventilator | Airon Corporation | 2004 | — |
| +1 | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| +2 | K092085 | Ispira Resuscitation Unit | Neoforce Group, Inc. | 2009 | — |
| +3 | K102649 | Neopop Infant Resuscitator with Flow Meter | Neoforce Group, Inc. | 2011 | — |
| +3 | K110119 | Pressure Manometer | Neoforce Group, Inc. | 2011 | — |
| +2 | K093862 | Carevent Handheld Cpap System | O-Two Medical Technologies, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 CBK? 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K024344 | Pneuton VentilatorSummary page 1…ct Code CBK) Device Class Class II Classification Panel Anesthesiology Predicate Devices Pneuton Transport Ventilator * manufactured by Airon Corporation * 510(k) number K024344 Pneupac Transport Ventilator * manufactured by Pneupac Ltd * 510(k) number K030803 * currently marketed in the USA through Smiths… | 2003 |
| * | K030803 | Parapac 200D Transport, Model V200DSummary page 1…vices Pneuton Transport Ventilator * manufactured by Airon Corporation * 510(k) number K024344 Pneupac Transport Ventilator * manufactured by Pneupac Ltd * 510(k) number K030803 * currently marketed in the USA through Smiths Medical Airon Corporation… | 2003 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 2 companies; a new generation was cleared every 16.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K080692 (Airon Corporation, 2008) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K024344.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The device is intended for continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified medical personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients, 23 kg (50 lbs.) and greater who require the following general types of ventilatory support: * positive…
Read the full statement (140 words)
The device is intended for continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified medical personnel under the direction of a physician.
Specifically, the ventilator is applicable for adult and pediatric patients, 23 kg (50 lbs.) and greater who require the following general types of ventilatory support:
* positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask)
CMV and IMV modes of ventilation
* with or without PEEP / CPAP
with oxygen or a mixture of air and oxygen
The ventilator is suitable for use in:
Pre-hospital transport applications including accident scene, emergency rescue vehicles
- Hospital ICU and transport applications including emergency, radiology, surgery, recovery and MRI departments
- Air transport via helicopter or fixed wing
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043085: Modification to: Pneuton Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043085
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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