# K090499: Lifedop Model, L350R

- Pathway: 510(k) (Traditional)
- Applicant: Summit Doppler Systems, Inc.
- Decided: Mar 31, 2009 after 34 days
- Product code: MAA (Monitor, Fetal Doppler Ultrasound)
- 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)
- K024197: Lifedop Doppler, Summit Doppler Systems, Inc. (2003) Summary page 1.

## Indications for use
Obstetrical: This. product will be used to detect fetal heart beats as an aid for determining fetal viability. Vascular: This product will also be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Source page: https://510kreport.com/device/K090499
Methodology: https://510kreport.com/methodology