510(k) · Cleared
ClearedCarevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and Carevent Atv
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O-Two Systems Intl., Inc. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Apr 22, 1999 as substantially equivalent to K983643 (O-Two Systems Intl., Inc., 1998) and 3 other predicates after a 14-day review. Its family tree reaches back 2 generations to 1993. 1 of the 10 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Apr 22, 1999
- Review
- 14 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K932170 (1993). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK932170 Flynnr Genesis II a/C, a/O and IdlhO-Two Systems Intl., Inc. · 1993
- 1 generation backK983643 Genesis BLSO-Two Systems Intl., Inc. · 1998
- This deviceK991195 Carevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and…O-Two Systems Intl., Inc. · 1999
- Descendant · cites it directly · 2 of its ownK081330 Carevent Par (Public Access Resuscitator)O-Two Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK141595 O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK113687 Equinox RelieveO-Two Medical Technologies, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK221634 Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A · 2023
- Descendant · 2 generations on · 0 of its ownK173205 Equinox AdvantageO-Two Medical Technologies, Inc. · 2018
Class I recalls in this family
- K141595 O-Two E700,O-Two E600,O-Two E5002 generations on · 2015
Most influential descendants
Showing 5 of 5 · See all- K081330Carevent Par (Public Access Resuscitator)O-Two Medical Technologies, Inc. · 2009 · cites it directly2descendants
- K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 2 generations on1descendant
- K113687Equinox RelieveO-Two Medical Technologies, Inc. · 2012 · cites it directly1descendant
- K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A · 2023 · 3 generations on0descendants
- K173205Equinox AdvantageO-Two Medical Technologies, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932170 | Flynnr Genesis II a/C, a/O and Idlh | O-Two Systems Intl., Inc. | 1993 | — |
| −1 | K983643 | Genesis BLS | O-Two Systems Intl., Inc. | 1998 | — |
| 0 (this device) | K991195 | Carevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and Carevent Atv | O-Two Systems Intl., Inc. | 1999 | — |
| +1 | K081330 | Carevent Par (Public Access Resuscitator) | O-Two Medical Technologies, Inc. | 2009 | — |
| +2 | K141595 | O-Two E700,O-Two E600,O-Two E500 | O-Two Medical Technologies, Inc. | 2015 | Class I |
| +1 | K113687 | Equinox Relieve | O-Two Medical Technologies, Inc. | 2012 | 2 |
| +3 | K221634 | Oxymag - Transport and Emergency Ventilator | Magnamed Tecnologia Medica S/A | 2023 | — |
| +2 | K173205 | Equinox Advantage | O-Two Medical Technologies, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 1 |
| 2018 | 1 | 0 |
| 2023 | 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.
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? (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 |
|---|---|---|---|
| * | K983643 | Genesis BLSSummary page 1…tator COMMON NAME: AUTOMATIC RESUSCITATOR REGULATORY CLASS: I 510K # : TO BE SUPPLIED LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED: GENESIS® BLS - 510K #: K983643 DESCRIPTION OF THE DEVICE: The CAREvent BLS automatic/manually triggered resuscitators are designed to provide respiratory supp… | 1998 |
| * | K932170 | Flynnr Genesis II a/C, a/O and IdlhSummary page 3…ator COMMON NAME: AUTOMATIC RESUSCITATOR REGULATORY CLASS: I 510K #: TO BE SUPPLIED LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED: GENESIS® Il A/C - 510K # K932170 DESCRIPTION OF THE DEVICE: The CAREvent ALS automatic/manually triggered resuscitators are designed to provide respiratory supp… | 1993 |
| * | K983785 | Autovent 1000Summary page 5…Automatic and Manual Ventilation into a control module with separate hose and patient valve This device is identical in terms of features to the Autovent 1000 - 510K #: K983785 with the addition of the ability to select the manual flowrate with a flowrate equivalent to that selected on the tidal volume/fr… | 1998 |
| * | K983857 | Autovent 1500Summary page 7…MMON NAME: AUTOMATIC TRANSPORT VENTILATOR REGULATORY CLASS: |l 510K # : TO BE SUPPLIED LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED: Autovent 1500 - 510K#: K983857 DESCRIPTION OF THE DEVICE: The CAREvent ATV is an automatic time cycled ventilator designed to provide respiratory support to p… | 1998 |
What descends from it? (5)
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.
- K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K081330 (O-Two Medical Technologies, Inc., 2009) has gone furthest, with 2 descendants 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?
Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients. Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients. Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and…
Read the full statement (100 words)
Pulmonary resuscitation during respiratory and/or cardiac arrest.
Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
Pulmonary resuscitation during respiratory and/or cardiac arrest.
Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
Pulmonary resuscitation during respiratory and/or cardiac arrest.
Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
Pulmonary resuscitation during respiratory and/or cardiac arrest.
Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
Pulmonary resuscitation during respiratory and/or cardiac arrest.
Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991195: Carevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and Carevent Atv.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991195
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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