# K050826: Fetal Ultrasound and Tocodynamometer Transducers

- Pathway: 510(k) (Traditional)
- Applicant: Cetro America
- Decided: Apr 10, 2006 after 374 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: 1 generation back to K852076 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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) Summary page 2.
- K852076: Model 145 Fetal Monitor, Ge Medical Systems Information Technologies (1985) Summary page 2.
- K900480: M1350A Fetal Monitor (Intrapartum), Hewlett-Packard Co. (1990) Summary page 2.
- K852518: Modification Fetal Monitor Model FM-2, Advantage Medical Systems, Inc. (1985) Summary page 2.
- K940898: Model IM77 Intrapartum Fetal Monitor, Advanced Medical Systems, Inc. (1995) Summary page 2.

## Indications for use
These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to obtain signals to monitor and chart Fetal Heart Rate and maternal uterine activity on a fetal monitor. Please refer to the chart below for appropriate replacement pairings:

Source page: https://510kreport.com/device/K050826
Methodology: https://510kreport.com/methodology