# K141877: Leaf Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Leaf Healthcare, Inc.
- Decided: Nov 10, 2014 after 122 days
- Product code: KMI (Monitor, Bed Patient)
- Device class: 1
- Regulation: 21 CFR 880.2400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K925529 (1993). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130752: Dynasense System, Centauri Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K191882: Masimo Centroid System (2020), 3 descendants of its own
- K223498: Radius VSM and Accessories (2023), 1 descendant of its own
- K253417: Masimo Root Monitoring System (2026), 0 descendants of its own
- K250757: Radius VSM and Accessories (2025), 0 descendants of its own
- K233096: PRESSUREALERT® Pressure Monitoring System (2024), 0 descendants of its own

## Indications for use
The Leaf Patient Monitoring System monitors the orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. The Leaf Patient Monitoring System provides alerts when patient orientation or activity deviates from parameters set by healthcare providers. The device is intended for use in medical, nursing and long-term care facilities, including independent living, assisted-living and rehabilitation facilities.

Source page: https://510kreport.com/device/K141877
Methodology: https://510kreport.com/methodology