510(k) · Cleared
ClearedAulisa Multiple Patient Digital Vital Sign Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiwan Aulisa Medical Devices Technologies, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Oct 30, 2020 as substantially equivalent to K151006 (Earlysense, Ltd., 2015) after a 60-day review. Its family tree reaches back 7 generations to 1993. 2 later devices descend from it.
- Decided
- Oct 30, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K925411 (1993). 15 ancestors in all, the oldest K913193 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
- 6 generations backK972121 Acuity Central StationProtocol Systems, Inc. · 1997
- 5 generations backK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
- 4 generations backK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · Recalled
- 3 generations backK120343 Connex WorkstationWelch Allyn, Inc. · 2012
- 2 generations backK132807 Monitoring Station, Connex (R) Central Station (CS)Welch Allyn, Inc. · 2014
- 1 generation backK151006 EarlySense Central Display Station (CDS)Earlysense, Ltd. · 2015
- This deviceK202497 Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK242842 ANNE View, Central HubSibel Health, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243837 iBSMIorbit Digital Technologies Private Limited · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K925411 | Model 2041-PC/ST Cardiac Telemetry Monitor | Accucore, Inc. | 1993 | — |
| −6 | K972121 | Acuity Central Station | Protocol Systems, Inc. | 1997 | — |
| −5 | K022453 | Modification to Acuity Central Monitoring System | Welch Allyn Protocol, Inc. | 2002 | 1 |
| −4 | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) | Welch Allyn, Inc. | 2005 | 2 |
| −3 | K120343 | Connex Workstation | Welch Allyn, Inc. | 2012 | — |
| −2 | K132807 | Monitoring Station, Connex (R) Central Station (CS) | Welch Allyn, Inc. | 2014 | — |
| −1 | K151006 | EarlySense Central Display Station (CDS) | Earlysense, Ltd. | 2015 | — |
| 0 (this device) | K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2020 | — |
| +1 | K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025 | — |
| +2 | K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K151006 | EarlySense Central Display Station (CDS)Summary page 4…l, 21 CFR 870.2300 Patient (Without Arrhythmia Class II MWI Detection or Alarms) 5.4. Predicate Device Predicate K151006, EarlySense Central Display Station, EarlySense Ltd.… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242842 | ANNE View, Central Hub | 2025 | 1 |
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 27 years and passes through 6 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K242842 (Sibel Health, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K151006.
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. 2020, 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 Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000, is intended to provide remote central monitoring and display of information as recorded by multiple Aulisa single-patient monitoring systems, on a central remote screen. The system can be used in a hospital type and clinic environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202497: Aulisa Multiple Patient Digital Vital Sign Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202497
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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