# K033156: OB1 Obstetrical Doppler

- Pathway: 510(k) (Traditional)
- Applicant: D. E. Hokanson, Inc.
- Decided: Dec 9, 2003 after 70 days
- Product code: KNG (Monitor, Ultrasonic, Fetal)
- Device class: 2
- Regulation: 21 CFR 884.2660
- 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 K930200 (1994). 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)
- K930200: Multi Dopplex II / Fetal Dopplex II, Huntleigh Healthcare, Inc. (1994) Summary page 1.
- K991441: Cadence Doppler Ultrasound System, Medasonics, Inc. (1999) Summary page 1.
- K024197: Lifedop Doppler, Summit Doppler Systems, Inc. (2003) Summary page 1.

## Indications for use
This product will be used to detect fetal heartbeats to help determine fetal viability.

Source page: https://510kreport.com/device/K033156
Methodology: https://510kreport.com/methodology