510(k) · Cleared
ClearedDigistat Care
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascom Ums Srl Unipersonale · MSX System, Network And Communication, Physiological Monitors
Cleared on Sep 12, 2026 as substantially equivalent to K211900 (Philips Medizin Systeme Böblingen GmbH, 2022) and 1 other predicate after a 145-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Sep 12, 2026
- Review
- 145 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962827 (1997). 9 ancestors in all, the oldest K945277 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 6 generations backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- 5 generations backK973527 Cardio-Pager SystemData Critical Corp. · 1998
- 4 generations backK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- 3 generations backK062278 Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc. · 2006
- 2 generations backK103634 Ascom Clinicalconnex CardiomaxAscom (Us), Inc. · 2011
- 1 generation backK180430 Digistat Smart CentralAscom Ums Srl Unipersonale · 2018
- This deviceK261287 Digistat CareAscom Ums Srl Unipersonale · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −6 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| −5 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| −4 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| −3 | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847 | Spacelabs Medical, Inc. | 2006 | — |
| −2 | K103634 | Ascom Clinicalconnex Cardiomax | Ascom (Us), Inc. | 2011 | — |
| −1 | K180430 | Digistat Smart Central | Ascom Ums Srl Unipersonale | 2018 | — |
| 0 (this device) | K261287 | Digistat Care | Ascom Ums Srl Unipersonale | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K211900 | Patient Information Center iXSummary page 5…are Regulations / Product Code, and Name Substantially Predicate 510(k) Predicate Manufacturer / Model Equivalent Devices: Number K211900 Philips Medizin Systeme Böblingen GmbH / Patient Information Center iX… | 2022 |
| * | K180430 | Digistat Smart CentralSummary page 5…eme Böblingen GmbH / Patient Information Center iX (primary) K180430 ASCOM UMS srl Unipersonale /… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 9 ancestors has a recall.
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. 2026, 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?
Digistat Care is stand-alone software intended to: • Receive, aggregate, process, display and distribute physiologic waves, parameters, alarms and events for multiple patients. • Generates alarm signals for user notification, based on the alarm signal determined and sent by compatible medical devices. • Provides ability to view alarms remotely. • Provides review and trend application data, designed to contribute to the screening of patient condition. All…
Read the full statement (172 words)
Digistat Care is stand-alone software intended to:
• Receive, aggregate, process, display and distribute physiologic waves, parameters, alarms and events for multiple patients.
• Generates alarm signals for user notification, based on the alarm signal determined and sent by compatible medical devices.
• Provides ability to view alarms remotely.
• Provides review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgment of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.
• Provides connection and information exchange to other systems not associated with active patient monitoring, such as information systems.
Digistat Care is intended for use by trained healthcare professionals in professional healthcare facilities and is not intended for home use. The mobile application may be used remotely to view patient data and alarms that are occurring on compatible medical devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261287: Digistat Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261287
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026