# K043075: Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring

- Pathway: 510(k) (Traditional)
- Applicant: Tenacore Holdings, Inc.
- Decided: Aug 18, 2005 after 283 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
Longest line of descent: 3 generations back to K911310 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891595: Model 116 Fetal Monitor, Ge Medical Systems Information Technologies (1989)
- K992811: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring, Epic Medical Equipment Services, Inc. (2000) Summary page 1.

## Indications for use
These transducers are intended to be used as replacement accessories for Hewlett Packard and Corometrics fetal monitors. These transducers measure fetal heart rate or uterine contractions in the gravid patient.

Source page: https://510kreport.com/device/K043075
Methodology: https://510kreport.com/methodology