# K261287: Digistat Care

- Pathway: 510(k) (Traditional)
- Applicant: Ascom Ums Srl Unipersonale
- Decided: Sep 12, 2026 after 145 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211900: Patient Information Center iX, Philips Medizin Systeme Böblingen GmbH (2022) Summary page 5.
- K180430: Digistat Smart Central, Ascom Ums Srl Unipersonale (2018) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K261287
Methodology: https://510kreport.com/methodology