# K192952: Spire Health Remote Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Spire, Inc. D/B/A Spire Health
- Decided: Jun 5, 2020 after 228 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: 37 generations back to K941811 (1994). 331 ancestors in all.
No later device cites it as a predicate yet.
2 of 332 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190073: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub, Current Health, Ltd. (2019) Summary page 4.
- K080545: Actitrainer, Actigraph, LLC (2008) Summary page 4.

## Indications for use
The Spire Health Remote Patient Monitoring System is intended for reusable bedside and mobile multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Spire Health Remote Patient Monitoring System is intended for longitudinal monitoring of the following parameters in adults: - Pulse Rate - Respiratory Rate - Sleep/Wake Behavior - Activity associated with Movement The Spire Health Remote Patient Monitoring System is intended only for general, non-diagnostic sleep and wake behavioral monitoring. It is not intended to assess sleep staging nor diagnose sleep disorders. The Spire Health Remote Patient Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Spire Health Remote Patient Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Spire Health Remote Patient Monitoring System is not a substitute for an ECG monitor.

Source page: https://510kreport.com/device/K192952
Methodology: https://510kreport.com/methodology