510(k) · Cleared
ClearedCarevent Atv+ and Carevent Mri
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 Sep 28, 2005 after a 117-day review. The FDA summary names no predicate by number. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Sep 28, 2005
- Review
- 117 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK051469 Carevent Atv+ and Carevent MriO-Two Medical Technologies, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK093862 Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK123957 Pneupac Parapac PlusSmiths Medical International, Ltd. · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK112546 O_Two Cpap SystemO-Two Medical Technologies, Inc. · 2011
Class I recalls in this family
- K123957 Pneupac Parapac Pluscites it directly · 2013
Most influential descendants
Showing 3 of 3 · See all- K093862Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 2010 · cites it directly1descendant
- K123957Pneupac Parapac PlusSmiths Medical International, Ltd. · 2013 · cites it directly0descendants
- K112546O_Two Cpap SystemO-Two Medical Technologies, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051469 | Carevent Atv+ and Carevent Mri | O-Two Medical Technologies, Inc. | 2005 | — |
| +1 | K093862 | Carevent Handheld Cpap System | O-Two Medical Technologies, Inc. | 2010 | — |
| +1 | K123957 | Pneupac Parapac Plus | Smiths Medical International, Ltd. | 2013 | Class I |
| +2 | K112546 | O_Two Cpap System | O-Two Medical Technologies, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K123957Pneupac Parapac PlusSmiths Medical International, Ltd. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 16 Class I recalls
What does this lineage say?
- Of its descendants, K093862 (O-Two Medical Technologies, Inc., 2010) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The CAREvent ATV+ and CAREvent MRI are pneumatically powered, time cycled, intermittent, positive pressure automatic transport ventilator used to provide resuscitation and/or ventilatory support to a wide range of patients (from above 5 kg (11 lbs.) and higher) during transport. They are designed to be used by suitably trained medical personnel in the pre-hospital, Intra-hospital, inter-hospital and air ambulance settings. In addition CAREvent MRI is…
Read the full statement (154 words)
The CAREvent ATV+ and CAREvent MRI are pneumatically powered, time cycled, intermittent, positive pressure automatic transport ventilator used to provide resuscitation and/or ventilatory support to a wide range of patients (from above 5 kg (11 lbs.) and higher) during transport. They are designed to be used by suitably trained medical personnel in the pre-hospital, Intra-hospital, inter-hospital and air ambulance settings. In addition CAREvent MRI is suitable for use in 1.5 - 3.0 Tesla MRI medical imaging suite environments, where ventilatory support may also be required during an MRI imaging procedure.
The ventilator is suitable for use in:
* Pulmonary resuscitation during respiratory and/or cardiac arrest.
* Short term ventilatory support in the pre-hospital, Intra-hospital, inter-hospital and air ambulance transport of non-breathing patients.
* In addition CAREvent MRI only is suitable for use in 1.5 - 3.0 Tesla MRI medical imaging suite environments, where ventilatory support may also be required during an MRI imaging procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051469: Carevent Atv+ and Carevent Mri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051469
Report an extraction error
Are you the manufacturer?
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