510(k) · Cleared
ClearedSRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Healthcare, Ltd. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Sep 6, 2019 as substantially equivalent to K930200 (Huntleigh Healthcare, Inc., 1994) and 1 other predicate after a 259-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.
- Decided
- Sep 6, 2019
- Review
- 259 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930200 (1994). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- This deviceK183574 SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes…Huntleigh Healthcare, Ltd. · 2019
- Descendant · cites it directly · 4 of its ownK200337 FloPatch (FP120)Flosonics Medical (R/A 1929803 Ontario Corp.) · 2020 · Recalled
- Descendant · 2 generations on · 3 of its ownK222242 FloPatch FP120Flosonics Medical · 2022
- Descendant · 3 generations on · 2 of its ownK223843 FloPatch FP120Flosonics Medical · 2023 · Recalled
- Descendant · 4 generations on · 1 of its ownK251114 FloPatch FP120Flosonics Medical · 2025
- Descendant · 5 generations on · 0 of its ownK252810 FloPatch FP120Flosonics Medical · 2026
Most influential descendants
Showing 5 of 5 · See all- K200337FloPatch (FP120)Flosonics Medical (R/A 1929803 Ontario Corp.) · 2020 · cites it directly4descendants
- K222242FloPatch FP120Flosonics Medical · 2022 · 2 generations on3descendants
- K223843FloPatch FP120Flosonics Medical · 2023 · 3 generations on2descendants
- K251114FloPatch FP120Flosonics Medical · 2025 · 4 generations on1descendant
- K252810FloPatch FP120Flosonics Medical · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| 0 (this device) | K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Huntleigh Healthcare, Ltd. | 2019 | — |
| +1 | K200337 | FloPatch (FP120) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2020 | 1 |
| +2 | K222242 | FloPatch FP120 | Flosonics Medical | 2022 | — |
| +3 | K223843 | FloPatch FP120 | Flosonics Medical | 2023 | 1 |
| +4 | K251114 | FloPatch FP120 | Flosonics Medical | 2025 | — |
| +5 | K252810 | FloPatch FP120 | Flosonics Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DPW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930200 | Multi Dopplex II / Fetal Dopplex IISummary page 5…MD2 family of Handheld vascular and obstetric Dopplers and (DMX / Vascular probes (HS range) manufactured by Huntleigh Healthcare Use) (K930200) Vascular Assist manufactured by Huntleigh Healthcare (K002186) Indications fo… | 1994 |
| * | K002186 | Vascular AssistSummary page 5…ctured by Huntleigh Healthcare Use) (K930200) Vascular Assist manufactured by Huntleigh Healthcare (K002186) Indications for Indicated for use by qualified healthcare practitioners in primary, Use: acute and… | 2001 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200337 | FloPatch (FP120) | 2020 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183574 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183574: SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183574
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026