# K891595: Model 116 Fetal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Jun 12, 1989 after 84 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.
7 later devices descend from it; 4 cite it directly.
0 of 8 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
- K982651: Corometrics Model 5700 and 2264 Watertight Transducer (1998), 3 descendants of its own
- K992811: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring (2000), 2 descendants of its own
- K061044: Featherlite Aqua Tocodynamometer (2006), 0 descendants of its own
- K050826: Fetal Ultrasound and Tocodynamometer Transducers (2006), 0 descendants of its own
- K043075: Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K891595
Methodology: https://510kreport.com/methodology