510(k) · Cleared
ClearedSmart Alarm Interface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boxview, LLC · MSX System, Network And Communication, Physiological Monitors
Cleared on Oct 30, 2020 as substantially equivalent to K111215 (Ascom (Sweden) AB, 2011) after a 326-day review. Its family tree reaches back 7 generations to 1997. 2 later devices descend from it.
- Decided
- Oct 30, 2020
- Review
- 326 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962827 (1997). 8 ancestors in all, the oldest K945277 (1995). 2 later devices descend from it, 2 citing it directly.
- 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 backK111215 Ascom Mobile Monitoring Gateway (MMG)Ascom (Sweden) AB · 2011 · Recalled
- This deviceK193421 Smart Alarm InterfaceBoxview, LLC · 2020
- Descendant · cites it directly · 0 of its ownK243270 TigerConnect Alarm ManagementTigerconnect · 2025
- Descendant · cites it directly · 0 of its ownK212622 Zyter RPMZyter, Inc. · 2022
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 | 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 | K111215 | Ascom Mobile Monitoring Gateway (MMG) | Ascom (Sweden) AB | 2011 | 1 |
| 0 (this device) | K193421 | Smart Alarm Interface | Boxview, LLC | 2020 | — |
| +1 | K243270 | TigerConnect Alarm Management | Tigerconnect | 2025 | — |
| +1 | K212622 | Zyter RPM | Zyter, Inc. | 2022 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111215 | Ascom Mobile Monitoring Gateway (MMG)Summary page 4…Primary Classification Regulation: 21 CFR §870.2300 Primary Product Code: MSX Predicate Device: Ascom Mobile Monitoring Gateway (MMG), K111215 K193421 – Page 1 of 8 510(k) Summary Subst… | 2011 |
What descends from it? (2)
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 23 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K243270 (Tigerconnect, 2025) has gone furthest, with 0 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. 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 intended use of the BoxView Smart Alarm Interface (SAI), Model SA-01 is to provide an interface with physiological patient monitoring systems to forward information associated to an alarm event to a designated display device(s). For medical, near real time alarms, the BoxView Smart Alarm Interface, Model SA-01 is intended to serve as a parallel, redundant, mechanism to inform healthcare professionals of particular medical alarm events. The BoxView…
Read the full statement (188 words)
The intended use of the BoxView Smart Alarm Interface (SAI), Model SA-01 is to provide an interface with physiological patient monitoring systems to forward information associated to an alarm event to a designated display device(s).
For medical, near real time alarms, the BoxView Smart Alarm Interface, Model SA-01 is intended to serve as a parallel, redundant, mechanism to inform healthcare professionals of particular medical alarm events. The BoxView Smart Alarm Interface, Model SA-01 does not alter the behavior of the primary medical devices and associated alarm annunciations.
The BoxView Smart Alarm Interface. Model SA-01 is intended for use as a secondary alarm notification system. It does not replace the primary alarm function on the monitor.
The BoxView Smart Alarm Interface. Model SA-01 is not intended to be used for diagnostic purposes. The BoxView Smart Alarm Interface, Model SA-01 is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the healthcare facility and the display devices used. The BoxView Smart Alarm Interface, Model SA-01 is a software product and cannot come into physical contact with patients.
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/K193421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193421: Smart Alarm Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193421
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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