510(k) · Cleared
ClearedCarevent Handheld Cpap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O-Two Medical Technologies, Inc. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on May 6, 2010 as substantially equivalent to K051469 (O-Two Medical Technologies, Inc., 2005) and 2 other predicates after a 140-day review. Its family tree reaches back 4 generations to 1986. 1 later device descends from it.
- Decided
- May 6, 2010
- Review
- 140 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K862830 (1986). 13 ancestors in all, the oldest K801883 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK862830 Models 2R and 3R Pneupac Ventilator/ResuscitatorPneupac, Ltd. · 1986
- 3 generations backK024344 Pneuton VentilatorAiron Corporation · 2003
- 2 generations backK043085 Modification to: Pneuton VentilatorAiron Corporation · 2004
- 1 generation backK080692 Macs Cpap SystemAiron Corporation · 2008
- This deviceK093862 Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK112546 O_Two Cpap SystemO-Two Medical Technologies, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K112546O_Two Cpap SystemO-Two Medical Technologies, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862830 | Models 2R and 3R Pneupac Ventilator/Resuscitator | Pneupac, Ltd. | 1986 | — |
| −3 | K024344 | Pneuton Ventilator | Airon Corporation | 2003 | — |
| −2 | K043085 | Modification to: Pneuton Ventilator | Airon Corporation | 2004 | — |
| −1 | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| 0 (this device) | K093862 | Carevent Handheld Cpap System | O-Two Medical Technologies, Inc. | 2010 | — |
| +1 | K112546 | O_Two Cpap System | O-Two Medical Technologies, Inc. | 2011 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K051469 | Carevent Atv+ and Carevent MriSummary page 1…CAREvent ATV+ Transport Ventilator * Manufactured by 0-Two Medical Technologies Inc. * 510(k) number K051469 MACS CPAP System * Manufactured by Airon Corporation… | 2005 |
| * | K080692 | Macs Cpap SystemSummary page 1…MACS CPAP System * Manufactured by Airon Corporation * 510(k) number K080692 Port0 2 Vent CPAP Oxygen Delivery System * Manufactured by E… | 2008 |
| * | K021520 | Emt-CpapSummary page 1…2 Vent CPAP Oxygen Delivery System * Manufactured by Emergency Respiratory Products a 5 10(k) number K021520 Device Description: The proposed CAREvent H-andheld CPAP System is a pneumatically powered device designed to provide CPAP (Co… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112546 | O_Two Cpap System | 2011 | 0 |
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 24 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K112546 (O-Two Medical Technologies, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051469.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The CAREvent Handheld CPAP System is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093862: Carevent Handheld 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/K093862
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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