# K233096: PRESSUREALERT® Pressure Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Position Health, LLC
- Decided: Jun 21, 2024 after 269 days
- Product code: SBO (Bed-Patient Activity Monitoring System)
- 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: 5 generations back to K925529 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141877: Leaf Patient Monitoring System, Leaf Healthcare, Inc. (2014) Summary page 5.

## Indications for use
The PRESSUREALERT® Pressure Monitoring System monitors the activity of patients who are susceptible to pressure ulcers by measuring pressure at various points of the body. It allows healthcare providers to execute an individualized turn management plan for each patient by continuously monitoring pressure on various points of the body of each patient. The PRESSUREALERT® Pressure Monitoring System provides alerts when patient activity deviates from the pressure prevention parameters set for by the 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/K233096
Methodology: https://510kreport.com/methodology