# K183638: SmartLinx Vitals Plus Patient Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Capsule Technologie
- Decided: Apr 17, 2019 after 112 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K200856: SmartLinx Vitals Plus Patient Monitoring System (2020), 1 descendant of its own
- K210204: Capsule Vitals Plus Patient Monitoring System (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K183638
Methodology: https://510kreport.com/methodology