# K183574: SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes

- Pathway: 510(k) (Abbreviated)
- Applicant: Huntleigh Healthcare, Ltd.
- Decided: Sep 6, 2019 after 259 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930200 (1994). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 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 5.
- K002186: Vascular Assist, Huntleigh Healthcare, Inc. (2001) Summary page 5.

## Most influential descendants
- K200337: FloPatch (FP120) (2020), 4 descendants of its own
- K222242: FloPatch FP120 (2022), 3 descendants of its own
- K223843: FloPatch FP120 (2023), 2 descendants of its own
- K251114: FloPatch FP120 (2025), 1 descendant of its own
- K252810: FloPatch FP120 (2026), 0 descendants of its own

## Indications for use
The DMX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the non-invasive assessment of vascular blood flow to assist in diagnosis. The SRX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of fetal heart rate to assist in diagnosis.

Source page: https://510kreport.com/device/K183574
Methodology: https://510kreport.com/methodology