510(k) · Cleared
ClearedBernoulli Management System, Oxinet Iii and Lifegard Vue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiopulmonary Corp. · MOD Accessory To Continuous Ventilator (Respirator)
Cleared on Aug 14, 2009 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 27 later devices descend from it.
- Decided
- Aug 14, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- MOD
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 2 citing it directly.
- This deviceK091461 Bernoulli Management System, Oxinet Iii and Lifegard VueCardiopulmonary Corp. · 2009
- Descendant · cites it directly · 22 of its ownK140339 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2014 · Recalled
- Descendant · 2 generations on · 18 of its ownK142732 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 3 generations on · 17 of its ownK151715 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 3 generations on · 16 of its ownK152258 T3 SoftwareEtiometry, Inc. · 2016
- Descendant · 4 generations on · 15 of its ownK163065 T3 SoftwareEtiometry, Inc. · 2017
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K140339Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2014 · cites it directly22descendants
- K142732T3 SoftwareEtiometry, Inc. · 2015 · 2 generations on18descendants
- K151715T3 SoftwareEtiometry, Inc. · 2015 · 3 generations on17descendants
- K152258T3 SoftwareEtiometry, Inc. · 2016 · 3 generations on16descendants
- K163065T3 SoftwareEtiometry, Inc. · 2017 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091461 | Bernoulli Management System, Oxinet Iii and Lifegard Vue | Cardiopulmonary Corp. | 2009 | — |
| +1 | K140339 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2014 | 2 |
| +2 | K142732 | T3 Software | Etiometry, Inc. | 2015 | — |
| +3 | K151715 | T3 Software | Etiometry, Inc. | 2015 | — |
| +3 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| +4 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOD? 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 MOD device
- #1 K261360 EasyCare Tx 2score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (27)
See all 272 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?
- Of its descendants, K140339 (Covidien, 2014) has gone furthest, with 22 descendants of its own.
How does its category compare?
All MOD devicesMOD Accessory To Continuous Ventilator (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MOD
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOD
125in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOD
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOD
1in 2022
MAUDE reports naming product code MOD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 125 | 1 | — |
What is it indicated for?
The Bernoulli MS software is intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital type environment. It is used to provide a secondary display of ventilator, respiratory monitor, IV infusion (including PCA) pump, feeding pump, and/or multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO 2, blood pressure, cardiac output, temperature and associated derived outputs) to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring procedures.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091461: Bernoulli Management System, Oxinet Iii and Lifegard Vue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091461
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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