510(k) · Cleared
ClearedFloPatch FP120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flosonics Medical · DPW Flowmeter, Blood, Cardiovascular
Cleared on Apr 24, 2026 as substantially equivalent to K251114 (Flosonics Medical, 2025) after a 233-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Apr 24, 2026
- Review
- 233 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930200 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 5 generations backK183574 SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes…Huntleigh Healthcare, Ltd. · 2019
- 4 generations backK200337 FloPatch (FP120)Flosonics Medical (R/A 1929803 Ontario Corp.) · 2020 · Recalled
- 3 generations backK222242 FloPatch FP120Flosonics Medical · 2022
- 2 generations backK223843 FloPatch FP120Flosonics Medical · 2023 · Recalled
- 1 generation backK251114 FloPatch FP120Flosonics Medical · 2025
- This deviceK252810 FloPatch FP120Flosonics Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −5 | K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Huntleigh Healthcare, Ltd. | 2019 | — |
| −4 | K200337 | FloPatch (FP120) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2020 | 1 |
| −3 | K222242 | FloPatch FP120 | Flosonics Medical | 2022 | — |
| −2 | K223843 | FloPatch FP120 | Flosonics Medical | 2023 | 1 |
| −1 | K251114 | FloPatch FP120 | Flosonics Medical | 2025 | — |
| 0 (this device) | K252810 | FloPatch FP120 | Flosonics Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (1)
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 |
|---|---|---|---|
| * | K251114 | FloPatch FP120Summary page 5…o modify the device’s indications for use. 4. Predicate Device Information 510(k) No. Device Manufacturer Primary: K251114 FloPatch FP120 Flosonics Medical 5. Device Description The FloPatch (FP120) is a non-inva… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 FloPatch FP120 is a wireless, non-invasive Doppler ultrasound system indicated to aid medical professionals as an adjunctive assessment in performing Critical Care Ultrasonography (CCUS) for Targeted Volume Management (TVM).
The FloPatch FP120 is indicated for use for the non-invasive assessment of blood flow in peripheral vasculature (including the carotid) in a target vessel. The device operates in a single mode, Continuous Wave (CW), providing quantitative flow metrics for arterial flow.
The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252810 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252810: FloPatch FP120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252810
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026