510(k) · Cleared
ClearedEarlySense Central Display Station (CDS)
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 Aug 31, 2015 as substantially equivalent to K121885 (Earlysense, Ltd., 2012) and 1 other predicate after a 138-day review. Its family tree reaches back 6 generations to 1993. 4 later devices descend from it.
- Decided
- Aug 31, 2015
- Review
- 138 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K925411 (1993). 14 ancestors in all, the oldest K913193 (1991). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
- 5 generations backK972121 Acuity Central StationProtocol Systems, Inc. · 1997
- 4 generations backK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
- 3 generations backK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · Recalled
- 2 generations backK120343 Connex WorkstationWelch Allyn, Inc. · 2012
- 1 generation backK132807 Monitoring Station, Connex (R) Central Station (CS)Welch Allyn, Inc. · 2014
- This deviceK151006 EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK202497 Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK242842 ANNE View, Central HubSibel Health, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK243837 iBSMIorbit Digital Technologies Private Limited · 2025
- Descendant · cites it directly · 0 of its ownK212622 Zyter RPMZyter, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020 · cites it directly2descendants
- K242842ANNE View, Central HubSibel Health, Inc. · 2025 · 2 generations on1descendant
- K243837iBSMIorbit Digital Technologies Private Limited · 2025 · 3 generations on0descendants
- K212622Zyter RPMZyter, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925411 | Model 2041-PC/ST Cardiac Telemetry Monitor | Accucore, Inc. | 1993 | — |
| −5 | K972121 | Acuity Central Station | Protocol Systems, Inc. | 1997 | — |
| −4 | K022453 | Modification to Acuity Central Monitoring System | Welch Allyn Protocol, Inc. | 2002 | 1 |
| −3 | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) | Welch Allyn, Inc. | 2005 | 2 |
| −2 | K120343 | Connex Workstation | Welch Allyn, Inc. | 2012 | — |
| −1 | K132807 | Monitoring Station, Connex (R) Central Station (CS) | Welch Allyn, Inc. | 2014 | — |
| 0 (this device) | K151006 | EarlySense Central Display Station (CDS) | Earlysense, Ltd. | 2015 | — |
| +1 | K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2020 | — |
| +2 | K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025 | — |
| +3 | K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025 | — |
| +1 | K212622 | Zyter RPM | Zyter, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K121885 | Earlysense Central Display SystemSummary page 4…Sec. 870.2300) Regulatory Class: II Product Code: MSX, MWI III. PREDICATE DEVICES Primary Predicate: EarlySense Central Display Station, K121885 Secondary Predicate: Connex Central Station, K132807 These predicates have not been subjects to a design-rel… | 2012 |
| * | K132807 | Monitoring Station, Connex (R) Central Station (CS)Summary page 4…X, MWI III. PREDICATE DEVICES Primary Predicate: EarlySense Central Display Station, K121885 Secondary Predicate: Connex Central Station, K132807 These predicates have not been subjects to a design-related recall. IV. DEVICE DESCRIPTION A traditional 510(k… | 2014 |
What descends from it? (4)
2 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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K202497 (Taiwan Aulisa Medical Devices Technologies, Inc., 2020) has gone furthest, with 2 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. 2015, 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 Central Display System is intended to provide remote central monitoring and display of information as recorded by multiple EarlySense bedside units, on a central remote screen. The system can be used in hospitals or hospital type and clinic environment.
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/K151006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151006: EarlySense Central Display Station (CDS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151006
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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