# K011903: Lifeshirt System with Vivologic Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Vivometrics, Inc.
- Decided: Apr 12, 2002 after 298 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942852 (1996). 2 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942852: Respitrace PT, Non-Invasive Monitoring Systems, Inc. (1996) Summary page 1.
- K001369: Respievents, Version 4.2, Non-Invasive Monitoring Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K070375: Earlysense ES-16 System (2007), 23 descendants of its own
- K082626: PAM 3000 (2009), 21 descendants of its own
- K082465: Everon (2009), 11 descendants of its own
- K092062: Everon 1.0 (2010), 10 descendants of its own
- K202464: Vital Sign Monitoring Sensor (Model :XK300) (2021), 9 descendants of its own

## Indications for use
The Life Shirt system is intended for use by one adult during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, and body position data may be collected. The system 1s intended to provide analysis of breathing patterns as an aid in classifying apneas as well as displaying heart rate changes from electrocardiographic waveforms in the wake and sleeping states as well as activities of daily living. Applications may include pharmaceutical studies in which respiratory informatiozi is a useful indicator, or the general healthcare market where patients may be monitored at home and the data provided to their physicians as an aid to diagnosis and treatment.

Source page: https://510kreport.com/device/K011903
Methodology: https://510kreport.com/methodology