# K040392: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring

- Pathway: 510(k) (Traditional)
- Applicant: American I.V. Products, Inc.
- Decided: Sep 14, 2004 after 210 days
- Product code: HFM (Monitor, Uterine Contraction, External (For Use In Clinic))
- Device class: 2
- Regulation: 21 CFR 884.2720
- 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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 6.
- K992811: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring, Epic Medical Equipment Services, Inc. (2000) Summary page 4.

## Indications for use
These devices are intended to be used as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient. AlV Transducer Model Numbers: FM10835 and FM10836. These devices are a direct replacement for the EPIC EFU200-20, Ultrasound Transducer for measuring fetal heart rate. AlV Transducer Model Numbers: FM10839 and FM10840. These devices are a direct replacement for the Corometric's 2264L.AX, TOCO Transducer for measuring uterine contractions. AlV Transducer Model Number: FM10841. This device is a direct replacement for the EPIC EFT200-20, TOCO Transducer for measuring uterine contractions.

Source page: https://510kreport.com/device/K040392
Methodology: https://510kreport.com/methodology