# K904745: Medi-Trace (R) Fetal Monitoring Spiral Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Graphic Controls Corp.
- Decided: Jan 29, 1991 after 103 days
- Product code: HGP (Electrode, Circular (Spiral), Scalp And Applicator)
- Device class: 2
- Regulation: 21 CFR 884.2675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030691: Fetal Spiral Electrode, Model FSE07000 (2003), 7 descendants of its own
- K080672: Birthtrack (2008), 5 descendants of its own
- K082704: Birthtrack (a.K.a. CLM) (2009), 4 descendants of its own
- K103172: Civ-OB (Plus) (2011), 3 descendants of its own
- K143695: Central Monitoring System (2015), 1 descendant of its own

Source page: https://510kreport.com/device/K904745
Methodology: https://510kreport.com/methodology