# K944497: Unilect, Monitab and Biotrace-HR

- Pathway: 510(k) (Traditional)
- Applicant: Msb, Ltd.
- Decided: May 17, 1996 after 612 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K101685: IP-SET (2010), 0 descendants of its own
- K071576: Textronics Ecg Electrode (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K944497
Methodology: https://510kreport.com/methodology