# K843385: Corometrics 115 Fetal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Nov 29, 1984 after 93 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 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
- K013477: Toco Lite, Model TD-01 (2002), 5 descendants of its own
- K090145: Surecall Emg Labor Monitor (2011), 2 descendants of its own
- K992811: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring (2000), 2 descendants of its own
- K140163: Koala Toco (2014), 0 descendants of its own
- K131889: Eum 100PRO (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K843385
Methodology: https://510kreport.com/methodology