# K990569: Baby Dopplex 4000, Model BD 4000

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Inc.
- Decided: Jan 24, 2000 after 335 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 K921957 (1993). 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)
- K963711: Baby Dopplex (3000), Huntleigh Healthcare, Inc. (1997) Summary page 1.
- K921957: Hewlett-Packard Model M1351A Fetal Monitor, Hewlett-Packard Co. (1993) Summary page 1.
- K921956: Hewlett Packard Model M1353A Fetal Monitor, Hewlett-Packard Co. (1993) Summary page 1.

## Indications for use
The Baby Dopplex® 4000 is a fetal monitor, which produces CTG’s and gives indication of uterine activity by processing received ultrasound/electrical signals. In basic format, the device performs antepartum fetal monitoring and uterine activity functions. Connecting separate modules to the Baby Dopplex® 4000 main unit allows it to perform Intrapartum monitoring operations. In instances of twin presentations, two basic Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

Source page: https://510kreport.com/device/K990569
Methodology: https://510kreport.com/methodology