# K012020: Respievents Software IS Event Data Processing Sofware for a PC

- Pathway: 510(k) (Special)
- Applicant: Non-Invasive Monitoring Systems, Inc.
- Decided: Aug 21, 2001 after 54 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 K001369 (2000). 1 ancestor in all.
1 later device descends 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)
- K001369: Respievents, Version 4.2, Non-Invasive Monitoring Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K153654: Sentry WEB SmartInterp (2016), 0 descendants of its own

## Indications for use
RespiEvents™ is a software package running on a personal computer that is intended to provide analysis of breathing patterns from RespiTrace technology, aid in identifying and classifying apneas, displaying heart rate changes from electrocardiographic waveforms, logging values from pulse oximetry, and displaying signals from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states as well as activities of daily living.

Source page: https://510kreport.com/device/K012020
Methodology: https://510kreport.com/methodology