# K241958: WARD-CSS (v1.2.x)

- Pathway: 510(k) (Traditional)
- Applicant: Ward 24/7 Aps
- Decided: Feb 14, 2025 after 226 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- 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: 30 generations back to K941811 (1994). 178 ancestors in all.
No later device cites it as a predicate yet.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213335: Capsule Surveillance System, Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. (2022) Summary page 5.

## Indications for use
WARD-CSS is a clinical decision support system that remotely integrates, analyzes and displays continuous vital sign data (via a mobile or web application) from medical devices for non-pediatric hospitalized patients within non-critical care units. WARD-CSS uses a set of standardized rules based on scientific and clinical evidence to detect and alert on clinically relevant vital sign deviations when used by trained health care professionals in hospitals. WARD-CSS is not intended to replace current monitoring practices or replace health care professionals’ judgment. WARD-CSS is a tool intended to help health care professionals manage monitored patients and make clinical care decisions.

Source page: https://510kreport.com/device/K241958
Methodology: https://510kreport.com/methodology