510(k) · Cleared
ClearedMacs Cpap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airon Corporation · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Jun 20, 2008 as substantially equivalent to K024344 (Airon Corporation, 2003) and 3 other predicates after a 101-day review. Its family tree reaches back 3 generations to 1986. 7 later devices descend from it.
- Decided
- Jun 20, 2008
- Review
- 101 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K862830 (1986). 11 ancestors in all, the oldest K801883 (1980). 7 later devices descend from it, 2 citing it directly.
- 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 deviceK080692 Macs Cpap SystemAiron Corporation · 2008
- Descendant · cites it directly · 4 of its ownK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK102649 Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK110119 Pressure ManometerNeoforce Group, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK093862 Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK142096 T-Piece ResuscitatorMercury Medical · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K092085Ispira Resuscitation UnitNeoforce Group, Inc. · 2009 · cites it directly4descendants
- K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011 · 2 generations on2descendants
- K110119Pressure ManometerNeoforce Group, Inc. · 2011 · 2 generations on1descendant
- K093862Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 2010 · cites it directly1descendant
- K142096T-Piece ResuscitatorMercury Medical · 2014 · 2 generations on0descendants
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) | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| +1 | K092085 | Ispira Resuscitation Unit | Neoforce Group, Inc. | 2009 | — |
| +2 | K102649 | Neopop Infant Resuscitator with Flow Meter | Neoforce Group, Inc. | 2011 | — |
| +2 | K110119 | Pressure Manometer | Neoforce Group, Inc. | 2011 | — |
| +1 | K093862 | Carevent Handheld Cpap System | O-Two Medical Technologies, Inc. | 2010 | — |
| +2 | K142096 | T-Piece Resuscitator | Mercury Medical | 2014 | — |
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 |
| 1990 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 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 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? (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 |
|---|---|---|---|
| * | K024344 | Pneuton VentilatorSummary page 1…TL and BYE) Device Class Class II Classification Panel Anesthesiology Predicate Devices Pneuton Transport Ventilator · manufactured by Airon Corporation · 510(k) number K024344 and K043085 PortO 2Vent CPAPos · manufactured by Emergent Respiratory Products * 510(k) number K021520 Whisperflow Oxygen Flow G… | 2003 |
| * | K043085 | Modification to: Pneuton VentilatorSummary page 1…Device Class Class II Classification Panel Anesthesiology Predicate Devices Pneuton Transport Ventilator · manufactured by Airon Corporation · 510(k) number K024344 and K043085 PortO 2Vent CPAPos · manufactured by Emergent Respiratory Products * 510(k) number K021520 Whisperflow Oxygen Flow Generator · m… | 2004 |
| * | K021520 | Emt-CpapSummary page 1…rt Ventilator · manufactured by Airon Corporation · 510(k) number K024344 and K043085 PortO 2Vent CPAPos · manufactured by Emergent Respiratory Products * 510(k) number K021520 Whisperflow Oxygen Flow Generator · manufactured by Caradyne Limited (now Respironics) * 510(k) number K982283… | 2002 |
| * | K982283 | Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow…Summary page 1…ufactured by Emergent Respiratory Products * 510(k) number K021520 Whisperflow Oxygen Flow Generator · manufactured by Caradyne Limited (now Respironics) * 510(k) number K982283 Airon Corporation 129 W. Hibiscus Blvd., Suite S Melbourne, FL 32901 US… | 1999 |
What descends from it? (7)
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 22 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K092085 (Neoforce Group, Inc., 2009) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K024344.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
To provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via Face Mask or endo-tracheal tube.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080692: Macs Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080692
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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