510(k) · Cleared
ClearedEarlysense Central Display System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Earlysense, Ltd. · MSX System, Network And Communication, Physiological Monitors
Cleared on Sep 10, 2012 as substantially equivalent to K110521 (Earlysense, Ltd., 2011) after a 74-day review. Its family tree reaches back 3 generations to 2006. 5 later devices descend from it.
- Decided
- Sep 10, 2012
- Review
- 74 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K061932 (2006). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK061932 Bernoulli Management System (MS) SoftwareCardiopulmonary Corp. · 2006
- 2 generations backK071047 Masimo Patient Safety NetMasimo Corporation · 2007
- 1 generation backK110521 Everon Central Display Station (CDS)Earlysense, Ltd. · 2011
- This deviceK121885 Earlysense Central Display SystemEarlysense, Ltd. · 2012
- Descendant · cites it directly · 4 of its ownK151006 EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK202497 Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK242842 ANNE View, Central HubSibel Health, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK243837 iBSMIorbit Digital Technologies Private Limited · 2025
- Descendant · 2 generations on · 0 of its ownK212622 Zyter RPMZyter, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K151006EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015 · cites it directly4descendants
- K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020 · 2 generations on2descendants
- K242842ANNE View, Central HubSibel Health, Inc. · 2025 · 3 generations on1descendant
- K243837iBSMIorbit Digital Technologies Private Limited · 2025 · 4 generations on0descendants
- K212622Zyter RPMZyter, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061932 | Bernoulli Management System (MS) Software | Cardiopulmonary Corp. | 2006 | — |
| −2 | K071047 | Masimo Patient Safety Net | Masimo Corporation | 2007 | — |
| −1 | K110521 | Everon Central Display Station (CDS) | Earlysense, Ltd. | 2011 | — |
| 0 (this device) | K121885 | Earlysense Central Display System | Earlysense, Ltd. | 2012 | — |
| +1 | K151006 | EarlySense Central Display Station (CDS) | Earlysense, Ltd. | 2015 | — |
| +2 | K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2020 | — |
| +3 | K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025 | — |
| +4 | K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025 | — |
| +2 | K212622 | Zyter RPM | Zyter, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K110521 | Everon Central Display Station (CDS) | 2011 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151006 | EarlySense Central Display Station (CDS) | 2015 | 4 |
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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K151006 (Earlysense, Ltd., 2015) has gone furthest, with 4 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. 2012, 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 EarlySense (Ever~n) Central Display Station (CDS) is intended to provide secondary display of the information as displayed on multiple individual bed side monitoring units, on a central remote screen. The EarlySense.(Ever~n) CDS is not intended to replace any part of the bed-side patient monitoring procedures. The system can be used in hospitals or hospital type and clinic environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121885 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121885: Earlysense Central Display System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121885
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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