510(k) · Cleared
ClearedPneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit Accessory
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 Oct 11, 2012 as substantially equivalent to K043085 (Airon Corporation, 2004) and 3 other predicates after a 156-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Oct 11, 2012
- Review
- 156 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K862830 (1986). 16 ancestors in all, the oldest K833982 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backK862830 Models 2R and 3R Pneupac Ventilator/ResuscitatorPneupac, Ltd. · 1986
- 2 generations backK024344 Pneuton VentilatorAiron Corporation · 2003
- 1 generation backK043085 Modification to: Pneuton VentilatorAiron Corporation · 2004
- This deviceK121379 Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv)…Airon Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862830 | Models 2R and 3R Pneupac Ventilator/Resuscitator | Pneupac, Ltd. | 1986 | — |
| −2 | K024344 | Pneuton Ventilator | Airon Corporation | 2003 | — |
| −1 | K043085 | Modification to: Pneuton Ventilator | Airon Corporation | 2004 | — |
| 0 (this device) | K121379 | Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit… | Airon Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 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.
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? (4)
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 |
|---|---|---|---|
| * | K043085 | Modification to: Pneuton VentilatorSummary page 1…or (21 CFR 868.5895, Product Code CBK) Device Class Class 11 Predicate Devices pNeuton Transport Ventilator model A * manufactured by Airon Corporation * 510(k) number K043085 BabyPAC 100 Ventilator * manufactured by Smiths Medical International Ltd. * 510(k) number K(043495 Millennium Infant Ventilato… | 2004 |
| * | K043495 | BabypacSummary page 1…tilator model A * manufactured by Airon Corporation * 510(k) number K043085 BabyPAC 100 Ventilator * manufactured by Smiths Medical International Ltd. * 510(k) number K(043495 Millennium Infant Ventilator * manufactured by Sechrist Industries Inc. * 510(k) number K(993167 Babi Plus Nasal Cannula System… | 2005 |
| * | K993167 | Millennium Infant VentilatorSummary page 3…Ventilator Ventilator Ventilator 510(k) number K043085 K(043495 K993167 Intended Use - Provide continuous or Provide continuous or Provide continuous Provide continuous applicatio… | 1999 |
| * | K110471 | Babi Plus Infant Nasal Cannula SystemSummary page 6…e with the Airon patient breathing circuit. One NIV kit is called the NIC OK CPAP Kit. This is the same device as the Babi Plus Infant Nasal Cannula System cleared under K1 10471 by A Plus Medical. The other NIV kit is called the NIC FM CPAP Kit. The NIC FM CPAP Kit is substantially equivalent in the indica… | 2011 |
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 26 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K043085.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support: * Positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask or nasal prongs) * CMV and IMV mode of ventilation with or without PEEP / CPAP * Provide oxygen or a mixture of medical air and oxygen Patient population: Neonates, infants, and children, from 400 g to.25…
Read the full statement (135 words)
The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support:
* Positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask or nasal prongs)
* CMV and IMV mode of ventilation with or without PEEP / CPAP
* Provide oxygen or a mixture of medical air and oxygen
Patient population:
Neonates, infants, and children, from 400 g to.25 kg in weight
Environments of Use
* Inter and intra-hospital patient transport
* Air & ground transport - Pressurized and non-pressurized aircraft (to 15,000 ft)
* Intensive care units (short term use only - associated with patient transport)
* Emergency Departments
* Radiology suites including MRI (MR Conditional 3T)
* Operating rooms (short term use only - associated with patient transport)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121379 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121379: Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121379
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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