# K942852: Respitrace PT

- Pathway: 510(k) (Traditional)
- Applicant: Non-Invasive Monitoring Systems, Inc.
- Decided: Feb 13, 1996 after 610 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
No predicates in its family tree.
27 later devices descend from it; 2 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K011903: Lifeshirt System with Vivologic Analysis Software (2002), 25 descendants of its own
- 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

Source page: https://510kreport.com/device/K942852
Methodology: https://510kreport.com/methodology