# K213335: Capsule Surveillance System

- Pathway: 510(k) (Traditional)
- Applicant: Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.
- Decided: Jan 14, 2022 after 100 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: 29 generations back to K941811 (1994). 177 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142106: Decisio Health Patient Dashboard, Decisio Health, Inc. (2015) Summary page 4.

## Most influential descendants
- K241958: WARD-CSS (v1.2.x) (2025), 0 descendants of its own
- K240756: Aitrics-VC (2024), 0 descendants of its own
- K233133: Talis EMR with Talis +ACG (Talis EMR with +ACG) (2024), 0 descendants of its own

## Indications for use
Capsule Surveillance is a clinical decision support device that integrates, analyzes, and displays data from multiple sources including medical devices and healthcare information systems. It uses standardized rules that are based on customers approved clinical practices, protocols, and policies to create clinically relevant alerts in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended to replace clinicians’ judgment, but rather to assist clinicians in making timely, informed, higher quality decisions. Capsule Surveillance may be configured for secondary monitoring and alerting intended to be relied upon in deciding to take immediate clinical action. Capsule Surveillance may also be configured for remote display of physiological data and alerts not intended to be relied upon in deciding to take immediate clinical action.

Source page: https://510kreport.com/device/K213335
Methodology: https://510kreport.com/methodology