510(k) · Cleared
ClearedBernoulli Management System (MS) Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiopulmonary Corp. · MSX System, Network And Communication, Physiological Monitors
Cleared on Sep 14, 2006 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it.
- Decided
- Sep 14, 2006
- Review
- 69 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK061932 Bernoulli Management System (MS) SoftwareCardiopulmonary Corp. · 2006
- Descendant · cites it directly · 7 of its ownK071047 Masimo Patient Safety NetMasimo Corporation · 2007
- Descendant · 2 generations on · 6 of its ownK110521 Everon Central Display Station (CDS)Earlysense, Ltd. · 2011
- Descendant · 3 generations on · 5 of its ownK121885 Earlysense Central Display SystemEarlysense, Ltd. · 2012
- Descendant · cites it directly · 5 of its ownK102974 Intellisphere Event Managment System Rel. 10.00Philips Medical Systems · 2011
- Descendant · 4 generations on · 4 of its ownK151006 EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K071047Masimo Patient Safety NetMasimo Corporation · 2007 · cites it directly7descendants
- K110521Everon Central Display Station (CDS)Earlysense, Ltd. · 2011 · 2 generations on6descendants
- K121885Earlysense Central Display SystemEarlysense, Ltd. · 2012 · 3 generations on5descendants
- K102974Intellisphere Event Managment System Rel. 10.00Philips Medical Systems · 2011 · cites it directly5descendants
- K151006EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061932 | Bernoulli Management System (MS) Software | Cardiopulmonary Corp. | 2006 | — |
| +1 | K071047 | Masimo Patient Safety Net | Masimo Corporation | 2007 | — |
| +2 | K110521 | Everon Central Display Station (CDS) | Earlysense, Ltd. | 2011 | — |
| +3 | K121885 | Earlysense Central Display System | Earlysense, Ltd. | 2012 | — |
| +1 | K102974 | Intellisphere Event Managment System Rel. 10.00 | Philips Medical Systems | 2011 | — |
| +4 | K151006 | EarlySense Central Display Station (CDS) | Earlysense, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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? (14)
See all 142 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, K071047 (Masimo Corporation, 2007) has gone furthest, with 7 descendants of its own.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
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, 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/K061932 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061932: Bernoulli Management System (MS) Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061932
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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