# K193421: Smart Alarm Interface

- Pathway: 510(k) (Traditional)
- Applicant: Boxview, LLC
- Decided: Oct 30, 2020 after 326 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962827 (1997). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111215: Ascom Mobile Monitoring Gateway (MMG), Ascom (Sweden) AB (2011) Summary page 4.

## Most influential descendants
- K243270: TigerConnect Alarm Management (2025), 0 descendants of its own
- K212622: Zyter RPM (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K193421
Methodology: https://510kreport.com/methodology