# K935020: Omni-Trac Modification

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Research, Inc.
- Decided: Apr 26, 1995 after 553 days
- Product code: MLD (Monitor, St Segment With Alarm)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
60 later devices descend from it; 1 cites it directly.
0 of 61 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
- K950264: Maglife (1996), 59 descendants of its own
- K023195: Maglife C/Maglife C Plus (2003), 57 descendants of its own
- K040915: Magnitude 3150M Mri Patient Monitor, Model 3150M (2004), 56 descendants of its own
- K050399: Mri Compatible Patient Monitoring System, Model 3160 (2005), 55 descendants of its own
- K053462: 3160 Mri Patient Monitoring System (2006), 53 descendants of its own

Source page: https://510kreport.com/device/K935020
Methodology: https://510kreport.com/methodology