# K040819: Transducer for Ultrasound Fetal Monitoring, Models FM10833 and FM10834

- Pathway: 510(k) (Traditional)
- Applicant: American I.V. Products, Inc.
- Decided: Aug 16, 2004 after 139 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: 2 generations back to K891595 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982651: Corometrics Model 5700 and 2264 Watertight Transducer, Corometrics Medical Systems, Inc. (1998) Summary page 1.

## Indications for use
These devices are intended to be used as replacement accessories to Corometrics Monitors, to measure fetal heart rate in the gravid patient.

Source page: https://510kreport.com/device/K040819
Methodology: https://510kreport.com/methodology