# K010889: Baby Dopplex 3000 MK 2 (BD3000)

- Pathway: 510(k) (Special)
- Applicant: Huntleigh Healthcare, Inc.
- Decided: Apr 25, 2001 after 30 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
No predicates in its family tree.
24 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040480: Sonotrax Ultrasonic Pocket Doppler (2004), 21 descendants of its own
- K080087: Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II Pro and Vascular (2008), 13 descendants of its own
- K092997: Ultrasonic Tabletop Doppler, Models SD5 and SD6 (2009), 7 descendants of its own
- K102138: Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler (2010), 5 descendants of its own
- K153475: SD5 & SD6 Ultrasonic Tabletop Doppler (2016), 4 descendants of its own

Source page: https://510kreport.com/device/K010889
Methodology: https://510kreport.com/methodology