510(k) · Cleared
ClearedDigistat Smart Central
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 Nov 23, 2018 as substantially equivalent to K103634 (Ascom (Us), Inc., 2011) after a 280-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.
- Decided
- Nov 23, 2018
- Review
- 280 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K962827 (1997). 7 ancestors in all, the oldest K945277 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 5 generations backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- 4 generations backK973527 Cardio-Pager SystemData Critical Corp. · 1998
- 3 generations backK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- 2 generations backK062278 Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc. · 2006
- 1 generation backK103634 Ascom Clinicalconnex CardiomaxAscom (Us), Inc. · 2011
- This deviceK180430 Digistat Smart CentralAscom Ums Srl Unipersonale · 2018
- Descendant · cites it directly · 0 of its ownK261287 Digistat CareAscom Ums Srl Unipersonale · 2026
Most influential descendants
Showing 1 of 1 · See all- K261287Digistat CareAscom Ums Srl Unipersonale · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −5 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| −4 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| −3 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| −2 | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847 | Spacelabs Medical, Inc. | 2006 | — |
| −1 | K103634 | Ascom Clinicalconnex Cardiomax | Ascom (Us), Inc. | 2011 | — |
| 0 (this device) | K180430 | Digistat Smart Central | Ascom Ums Srl Unipersonale | 2018 | — |
| +1 | K261287 | Digistat Care | Ascom Ums Srl Unipersonale | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261287 | Digistat Care | 2026 | 0 |
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 21 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K261287 (Ascom Ums Srl Unipersonale, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K103634.
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. 2018, 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 intended use of the Digistat Smart Central is to provide an interface with clinical systems to forward information associated to the particular event from patient monitors, ventilators, and infusion pumps to the designated display device(s). For medical, near real time alarms, the Digistat Smart Central is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The…
Read the full statement (123 words)
The intended use of the Digistat Smart Central is to provide an interface with clinical systems to forward information associated to the particular event from patient monitors, ventilators, and infusion pumps to the designated display device(s). For medical, near real time alarms, the Digistat Smart Central is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Digistat Smart Central does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert.
The Digistat Smart Central is intended for use as a secondary alarm. It does not replace the primary alarm function on the medical devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180430 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180430: Digistat Smart Central.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180430
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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