510(k) · Cleared
ClearedMasimo Patient Safety Net
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · MSX System, Network And Communication, Physiological Monitors
Cleared on Jun 8, 2007 as substantially equivalent to K061932 (Cardiopulmonary Corp., 2006) after a 56-day review. Its family tree reaches back 1 generation to 2006. 7 later devices descend from it.
- Decided
- Jun 8, 2007
- Review
- 56 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061932 (2006). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK061932 Bernoulli Management System (MS) SoftwareCardiopulmonary Corp. · 2006
- This deviceK071047 Masimo Patient Safety NetMasimo Corporation · 2007
- Descendant · cites it directly · 6 of its ownK110521 Everon Central Display Station (CDS)Earlysense, Ltd. · 2011
- Descendant · 2 generations on · 5 of its ownK121885 Earlysense Central Display SystemEarlysense, Ltd. · 2012
- Descendant · 3 generations on · 4 of its ownK151006 EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015
- Descendant · 4 generations on · 2 of its ownK202497 Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020
- Descendant · 5 generations on · 1 of its ownK242842 ANNE View, Central HubSibel Health, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K110521Everon Central Display Station (CDS)Earlysense, Ltd. · 2011 · cites it directly6descendants
- K121885Earlysense Central Display SystemEarlysense, Ltd. · 2012 · 2 generations on5descendants
- K151006EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015 · 3 generations on4descendants
- K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020 · 4 generations on2descendants
- K242842ANNE View, Central HubSibel Health, Inc. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061932 | Bernoulli Management System (MS) Software | Cardiopulmonary Corp. | 2006 | — |
| 0 (this device) | K071047 | Masimo Patient Safety Net | Masimo Corporation | 2007 | — |
| +1 | K110521 | Everon Central Display Station (CDS) | Earlysense, Ltd. | 2011 | — |
| +2 | K121885 | Earlysense Central Display System | Earlysense, Ltd. | 2012 | — |
| +3 | K151006 | EarlySense Central Display Station (CDS) | Earlysense, Ltd. | 2015 | — |
| +4 | K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2020 | — |
| +5 | K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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 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? (1)
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 |
|---|---|---|---|
| * | K061932 | Bernoulli Management System (MS) SoftwareSummary page 1…munication, Physiological Monitors Substantially Equivalent Devices: Bernoulli Management System 510(k) Number - K061932 Description of Masimo Patient Safety Net The Masimo Patient Safety Net (PSN) is a supplemental alarm system for physiological… | 2006 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110521 | Everon Central Display Station (CDS) | 2011 | 6 |
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?
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. 2007, this device’s year, is highlighted.
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 Masimo Patient Safety Net (PSN) is intended to be used as a supplemental alarm system, communicating with multiple patient monitoring devices. The PSN provides secondary display of physiological monitoring parameters. It enables the viewing and monitoring of patient physiological conditions. The PSN is used in hospitals or hospital-type environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071047: Masimo Patient Safety Net.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071047
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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